MAUDE Adverse Event Report: WILSON-COOK MEDICAL, INC. FUSION QUATTRO; CATHETER

Catalog Number G31921

Device Problem Inflation Problem (1310)

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

Event Date 08/29/2014

Event Type  malfunction  

Event Description

Dilation balloon defective, tested before use and was working and after one use the balloon does not remain inflated.

• Brand Name: FUSION QUATTRO
• Type of Device: CATHETER
• Manufacturer (Section D): WILSON-COOK MEDICAL, INC.; 4900 bethania station road; winston-salem NC 27105
• MDR Report Key: 4120641
• MDR Text Key: 4796908
• Report Number: 4120641
• Device Sequence Number: 1
• Product Code: GCA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: G31921
• Device Lot Number: W3457325
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/03/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2014
• Patient Sequence Number: 1
• Patient Age: 75 YR