MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	G52252
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be submitted upon completion.
Event or Problem Description
A fistulogram was being performed via the upper arm of a patient, and a physician was using a low profile balloon catheter with equal parts isoview 300 and saline.It was reported that during the procedure the balloon burst at lower than the burst pressure.When asked what the inflation pressure was, it was provided by the complainant that they were "not sure but below burst pressure." no adverse effects were reported prior to the occurrence, and no additional procedures were needed.
Additional Manufacturer Narrative
Corrected information: pma/510(k) #: k091527 investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used advance 35 lp low profile balloon catheter was returned in a damaged condition.Bio-material was cleared from lumen attempt was made to inflate the balloon, a pinhole was noted at the proximal end of the balloon.The length of the device was within specifications.The balloon length of the device was within specifications.There was no damage noted to the catheter.The balloon did not burst longitudinally or circumferentially.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.The balloon is 100% inspected and verified prior to release.There is no mention of calcifications or other human anatomy characteristics that may have contributed to the device failure.There is no mention of preparation of the device prior to patient contact that may have contributed to the device failure.The device did not rupture.Based on the information provided, examination of the returned product, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6713462
• Report Number: 1820334-2017-01726
• Device Sequence Number: 13698927
• Product Code: DQY
• UDI-Device Identifier: 10827002522524
• UDI-Public: (01)10827002522524(17)200330(10)7790582
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G52252
• Device Catalogue Number: PTA5-35-135-4-4.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/20/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 07/14/2017
• Supplement Report FDA Received Date: 10/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1