Case Archive
Biomedical Engineering

Rotablator® System Fails During Atherectomy
Confidential Settlement

A 49-year-old man was diagnosed with mild diffuse coronary blockage. The next day the cardiologist took the patient to the hospital's Cardiac Cath Lab for a Percutaneous Transluminal Coronary Rotational Angioplasty (PTCRA), a routine non-surgical treatment to open blocked arteries. The medical device employed was a Rotablator® Rotational Atherectomy System, manufactured by Boston Scientific Corp. During the procedure the braking mechanism of the Rotablator® System malfunctioned, causing unwanted movement of the guide wire and burr and resulting in severe lacerations to the heart and surrounding tissue. The cardiologist discovered the spring tip was missing. The heart monitor showed blush, indicating bleeding in the heart's tissue. The procedure was halted and the patient was sent to recovery. Two hours later the patient's blood pressure dropped sharply. A cardiovascular surgeon was called and he rushed the patient to emergency surgery. Upon the opening of the chest cavity, a hemorrhagic infarction was discovered. The patient expired on the operating table. The Rotablator® system was recalled three months after the patient's death. A medQuest biomedical engineer inspected the system and accessories in question, comparing them to new versions of the same models. The expert reviewed records including the manufacturer's manuals and reference guides, U.S. patent office records, and clinical publications about rotational coronary atherectomy. The brake in question failed because its seal was too small. The manufacturer had not allowed for additional shrinkage of the seal after sterilization of equipment prior to surgery. In reviewing the FDA database of Pre-Market Approval (PMA), the expert found Boston Scientific Corp. had submitted 67 applications for manufacturing process and instruction changes associated with the brake mechanism, indicating the system's introduction was premature and further testing and validation were required. The expert testified at deposition that the Rotablator® system was poorly designed and unsafe for its indicated application at the time it was deployed. According to the attorneys, a confidential settlement was reached between the decedent's family, Boston Scientific Corp. and the cardiologist.

Attorney for the Plaintiff:
Ricardo A. Garcia, Esq.
Law Office of Ricardo A. Garcia
McAllen, TX

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