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

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
An advance 35 lp low profile balloon catheter was used in a peripheral percutaneous transluminal angioplasty.It was reported that, during inflation, the balloon burst.The vessel was reported to be calcified.Another device was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, documentation, manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.One advance 35 lp low profile balloon catheter, was returned for investigation separated.Distal portion of balloon and distal end of catheter missing.Balloon tubing is stretched.Only proximal marker band was returned.Distal end of balloon tubing is frayed.Kink is noted in catheter at 103.3 cm from the proximal end.In the devices returned state, dimensional requirements did not meet specifications.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.A review of the device history record showed two no non-conforming events which were not related to the reported issue, in addition, all non-conforming product was reworked prior to completion of the final lot.There were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation; a definitive root cause could not be determined.However, appropriate measures have been initiated to address this failure mode.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: 6962022
• Report Number: 1820334-2017-03635
• Device Sequence Number: 10942449
• Product Code: DQY
• UDI-Device Identifier: 10827002522722
• UDI-Public: (01)10827002522722(17)200815(10)8142104
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,health
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

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: N/A
• Device Catalogue Number: PTA5-35-135-7-4.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/16/2017
• Supplement Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 10/19/2017
• Supplement Report FDA Received Date: 01/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1