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Common name & product code: unavailable as the device lot number, rpn, and gpn are unknown.Pma/510(k) number: unavailable as the device lot number, rpn, and gpn are unknown.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
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It was reported, a patient was undergoing a planned procedure to dilate a severely calcified common iliac artery in the right leg which had been stented some years before, implant date and stent manufacturer unknown.Another manufacturer's introducer caught on the stent and an effort was made to re-modulate the stent using advance pta 5 balloon catheters, which perforated.These were easily removed from the patient's anatomy.Subsequently, a stent-in-stent procedure was performed.While post-dilating the stent with an advance 35 lp low profile balloon catheter.The balloon catheter ruptured circumferentially during the first inflation at 7 atmospheres just prior to reaching nominal pressure.Another manufacturer's inflation device was used for the inflation.Ultravist contrast and normal saline were used in a 1 to 1 ratio.While trying to remove the ruptured advance 35 lp low profile balloon catheter through another manufacturer's introducer the balloon tore at the top.An attempt was made to retrieve the torn piece through a second 8 french (fr) introducer using a snare device but this was not successful.The procedure was aborted at this point and the patient required surgery to completely remove the retained piece of the balloon.The surgery was successful and the patient was fine.The original procedure was rescheduled for another date.No further adverse effects have been reported.Additional information has been requested regarding the number of advance pta 5 balloon catheters which perforated and to ascertain the product and lot numbers.According to the company representative, no further information is available at this time.This report is for the perforated balloons and there was no adverse patient effect as a result of that event.The surgical procedure noted above was as a result of a separate advance pta balloon rupture.Please reference medwatch 1820334-2018-03500 which was submitted to capture the balloon rupture and tear as well as the piece of the balloon retained in the patient's anatomy and the aborted procedure.
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Additional information: additional information was received from the customer.Product information for the complaint device was confirmed upon request.Additionally, it was confirmed that only one advance 35 lp low profile balloon catheter had a hole.Investigation - evaluation.A review of the complaint history, device history record, documentation, drawing, instructions for use, manufactures instructions, and quality control was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The exact lot for this device is unknown.However, sales records were reviewed and it was found that eight (8) pta5-35-80-8-2.0 devices from seven (7) different lots had been shipped to the customer between 01jan2018 and 17oct2018 (the date of the event).The device history records for these device lots were reviewed and any potentially related nonconformances that were noted from these lots were scrapped and not replaced.There is no evidence to suggest that this device was not manufactured to specification.It should also be noted that there were no other complaints for the potential lot numbers.The device is shipped with instruction for use (ifu) which notes the use of this device is for percutaneous transluminal angioplasty (pta) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral, and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae." it goes on to state "the catheter is not intended for the delivery of stents." as well as ¿if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit." based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be traced to the device, but instead is related to the procedure performed.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Measures are being conducted to address this failure mode.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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