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As reported, during a procedure involving placement of a stent, an advance 35 lp low profile balloon catheter ruptured at nine atmospheres and a pinhole leak was noted.Access was obtained in the right femoral artery and a contralateral approach was used to treat the severely stenosed and severely calcified lesion in the middle of the left femoral artery.Another manufacturer's sheath and wire guide were used during the procedure.An unknown inflation device was used to inflate the balloon one time, at which point the balloon ruptured.The balloon was removed by itself and a larger cook advance balloon was used to dilate the target site.The stent was placed and the procedure was completed.There were no reported adverse effects to the patient.
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Customer name and address= address line 2: (b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during a procedure involving placement of a stent, an advance 35 lp low profile balloon catheter ruptured at nine atmospheres and a pinhole leak was noted.Access was obtained in the right femoral artery and a contralateral approach was used to treat the severely stenosed and severely calcified lesion in the middle of the left femoral artery.Another manufacturer's sheath and wire guide were used during the procedure.An unknown inflation device was used to inflate the balloon one time, at which point the balloon ruptured.The balloon was removed by itself, and a larger cook advance balloon was used to dilate the target site.The stent was placed, and the procedure was completed.There were no reported adverse effects to the patient.Investigation evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), specifications, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The product ifu states, ¿upon removal from the package, inspect the catheter to ensure no damage has occurred during shipping.¿ the information provided upon review of the dmr, dhr, and ifu provides evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that the patient¿s severely calcified anatomy contributed to this event.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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