MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number G35532

Device Problems Balloon (419); Hole In Material (1293); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2017

Event Type  Malfunction  

Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol_(b)(4), compliant/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.

Event Description

When attempting to inflate the balloon it would not hold pressure. When the balloon was observed a pinhole was noted in the balloon. No adverse event were reported.

• Brand Name: ADVANCE 35 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 Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6707095
• MDR Text Key: 80027754
• Report Number: 1820334-2017-01889
• 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: USER FACILITY

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/12/2017

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 07/12/2017
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: G35532
• Device Catalogue Number: PTA5-35-135-5-20.0
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 04/06/2016
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial