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

Catalog Number G48225

Device Problem Deflation Problem (1149)

Patient Problem No Information (3190)

Event Date 10/22/2013

Event Type  malfunction  

• Brand Name: FUSION QUATTRO
• Type of Device: CATHETER, BILIARY, SURGICAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC.; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 3861320
• Report Number: 3861320
• 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: 04/30/2014

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: Invalid Data
• Device Catalogue Number: G48225
• Device Lot Number: W3333045
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/28/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/28/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1