MAUDE Adverse Event Report: COOK INCORPORATED FUSION QUATTRO; CATHETER, BILIARY, SURGICAL

Model Number G48225

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528)

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

Event Date 06/05/2017

Event Type  malfunction  

Event Description

When attempting to remove balloon by gi, it was noticed balloon had broken off and could not be removed by hemostat.Since the balloon broke free from apparatus which was maintaining inflation, it should no longer be inflated.Small, flexible catheter may well pass spontaneously per rectum.Doctor to follow patient with serial kubs-kidneys, ureters, and bladder.

• Brand Name: FUSION QUATTRO
• Type of Device: CATHETER, BILIARY, SURGICAL
• Manufacturer (Section D): COOK INCORPORATED; 6300 n. matthews dr.; ellettsville IN 47429
• MDR Report Key: 6837459
• MDR Text Key: 84326786
• Report Number: 6837459
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2017

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 Catalogue Number: FS-QEB-A
• Device Lot Number: W3837340
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 45