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

Model Number G50339

Device Problem Peeled/Delaminated (1454)

Patient Problem No Patient Involvement (2645)

Event Date 12/12/2019

Event Type  Malfunction  

Manufacturer Narrative

Occupation = unknown. Pma/510(k) number= k170193. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, prior to patient contact during an angiogram of the lower leg, "plastic strands" came off of an advance 14 lp low profile balloon catheter balloon as it was wiped down. The strands were approximately one inch in length. The device did not make patient contact. 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.

• 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jennifer canada ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 9539150
• MDR Text Key: 178146013
• Report Number: 1820334-2020-00032
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,USER F

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/29/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 01/02/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: G50339
• Device Catalogue Number: PTAX4-14-170-4-16
• Device LOT Number: 9903180
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/17/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 07/24/2019
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial