MAUDE Adverse Event Report: COOK INC ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number PTA3-14-90-3-4

Device Problem Material Frayed (1262)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2018

Event Type  malfunction  

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported, the advance micro¿ 14 ultra low-profile pta balloon catheter was found frayed prior to a peripheral arteriogram procedure.The frayed device was noted while on the preparation table.A second balloon device was used to complete the procedure successfully.No adverse effects have been reported regarding this incident.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.A review of the dimensional verification, interview personnel, complaint history, device history record, trends, and a functional test & a visual inspection of the returned device were conducted during the investigation.The visual inspection and functional test of the returned device confirmed that the balloon was returned with a wire guide.The wire guide was inserted in the balloon catheter and protruded out the proximal end by 207.7cm.At this point, the wire guide could not be removed.Upon further inspection, dried contrast was noted inside the balloon and impressions were noted on the length of the balloon.The catheter tubing inside the balloon was folded (kinked) on itself - 4mm in length, 2.4cm from the distal end of the catheter.Furthermore, during the inflation attempt, leakage was noted at the distal port of the hub.The device did inflate, but at a low pressure.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Moreover, a review of the manufactures instructions and quality control did not reveal anything noteworthy.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7773357
• MDR Text Key: 116869238
• Report Number: 1820334-2018-02336
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10827002266053
• UDI-Public: (01)10827002266053(17)210411(10)8765543
• Combination Product (y/n): N
• PMA/PMN Number: K122940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/02/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2021
• Device Catalogue Number: PTA3-14-90-3-4
• Device Lot Number: 8765543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2018
• Supplement Dates Manufacturer Received: 10/25/2018
• Supplement Dates FDA Received: 11/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1