MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number	PTAX4-14-170-3-20
Medical Device Problem Codes	Material Frayed (1262); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that when the advance 14 lp low profile balloon catheter was removed from its sterile package, the physician noticed that the balloon material was frayed, bubbled, and not smooth as it should be.The device did not make contact with the patient.The male patient was to receive intervention for critical limb ischemia in an unspecified leg.A new advance 14 lp low profile balloon catheter was used and the procedure was successfully completed.According to the initial reporter, the patient did not experience any adverse effects as a result of this occurrence.
Additional Manufacturer Narrative
A review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, trends, quality control, and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device confirmed there were bubbles and small strands on the surface of the balloon.Additionally, 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 18 nonconforming events that could contribute to this failure mode; however, there is no evidence to suggest all items in this lot or similar devices, in house or in the field, are non conforming.It should be noted there was one other reported complaint for this lot number; however, for an issue which was not related to the reported failure mode in this case.Based on the information provided and the results of our investigation, the root cause has been found to be manufacturing related; however, appropriate measures have been initiated to address this failure mode.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ADVANCE 14 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: 7502458
• Report Number: 1820334-2018-01351
• Device Sequence Number: 169011
• Product Code: DQY
• UDI-Device Identifier: 10827002503332
• UDI-Public: (01)10827002503332(17)210201(10)8555123
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K090822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2018

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 Catalogue Number: PTAX4-14-170-3-20
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 07/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1