MAUDE Adverse Event Report: COOK INCORPORATED ADVANCE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number G50315

Device Problems Material Separation (1562); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/23/2020

Event Type  malfunction  

Event Description

Doctor reports that when he visually inspected the balloon before using, he noted there was separation where the balloon meets the shaft, which meant that it was defective and would not inflate. He did not put the balloon in the body. He recognized that it was defective first.

• Brand Name: ADVANCE
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10918867
• MDR Text Key: 218685038
• Report Number: 10918867
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/11/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: G50315
• Device Catalogue Number: PTAX4-14-170-2-6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/11/2020
• Event Location: No Information
• Date Report to Manufacturer: 11/30/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown