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

Model Number G48225

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 12/22/2014

Event Type  malfunction  

Event Description

Balloon opened and checked before procedure balloon inlfated.During procedure balloon swept once and broke.

• Brand Name: FUSION QUATTRO
• Type of Device: CATHER, BALLOON
• Manufacturer (Section D): WILSON-COOK MEDICAL INC.; 4900 bethaia station road; winston-salem NC 27105
• MDR Report Key: 4390784
• MDR Text Key: 5363504
• Report Number: 4390784
• Device Sequence Number: 1
• Product Code: EZL
• 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: 12/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: G48225
• Device Lot Number: W3495505
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR