MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number G50338

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) number = k170193.Device evaluated by mfg = other - device evaluation has begun; however, a conclusion is not yet available.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 initially reported that during an endovascular treatment (evt) procedure, it was difficult for a guide wire to be removed from the wire/exchange port of an advance 14 lp low profile balloon catheter, and was withdrawn via the hub instead of the complaint device without issue.This was observed as the physician attempted to advance the complaint device over another manufacturer's wire guide that was already in the patient.The balloon catheter was flushed prior to insertion.The complaint device was replaced with another manufacturer's balloon catheter and the procedure was completed.Upon return to the manufacturer, and during investigation of the device, a pinhole in the balloon material was observed.There has been no report that any part of the device remained in the patient's body, that the patient required any additional procedures, or that the patient experienced any adverse effects due to this event.

Event Description

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

Manufacturer Narrative

Investigation/evaluation: a review of the complaint history, device history record, instructions for use (ifu), functional testing, quality control, and visual inspection of the returned device was conducted during the investigation.The visual inspection and functional testing of the used, returned device confirmed a patency between the balloon lumen into the area of the wire lumen causing leakage.A leak from the balloon lumen was found during investigation.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 for the complaint lot and subassembly lot which could contribute to this failure mode.It should be noted there was one other reported complaints for this lot number.The product labeling accurately describes the device and provides instructions on how to use the device.Furthermore, reviews of the manufactures instructions and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and the examination of the returned product, investigation has concluded the cause of this event is due to the device design.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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.

• Brand Name: ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
• Type of Device: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8310335
• MDR Text Key: 135190657
• Report Number: 1820334-2019-00341
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002503387
• UDI-Public: (01)10827002503387(17)211101(10)9278351
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2021
• Device Model Number: G50338
• Device Catalogue Number: PTAX4-14-170-4-12
• Device Lot Number: 9278351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Date Manufacturer Received: 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORSAIR/ASAHI INTECC- 14-INCH COMMAND/ABBOTT; CORSAIR/ASAHI INTECC- 14-INCH COMMAND/ABBOTT