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	08/28/2017
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 non-stent angioplasty.It was reported that the balloon's nominal pressure was 14 and ruptured while being inflated.The rupture was reported to have occurred prior to reaching the maximum pressure.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, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, and quality control was conducted during the investigation.The complainant device was not returned for evaluation nor images provided for review.A representative advance 35 lp low profile balloon catheter from lot 8175487 was evaluated.The balloon catheter was unopened and in the spiral shipping holder.Crow¿s feet were observed on the balloon.No damage was noted to the catheter shaft.Balloon was inflated to 16 atmosphere (atm) and the balloon did not rupture.This test result exceeded the 15 atm maximum inflation requirement.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 could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, a definitive root cause cannot be determined at this time, 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: 6963197
• Report Number: 1820334-2017-03528
• Device Sequence Number: 1325225
• Product Code: DQY
• UDI-Device Identifier: 10827002522531
• UDI-Public: (01)10827002522531(17)200131(10)7635912
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2017

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: N/A
• Device Catalogue Number: PTA5-35-135-4-8.0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 10/19/2017
• Supplement Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1