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

Model Number G48225

Device Problem Material Twisted/Bent (2981)

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

Event Date 01/20/2022

Event Type  malfunction  

Event Description

Cook endoscopy (endoscopic retrograde cholangiopancreatography) ercp device was used during an ercp and was believed to have malfunctioned.The fusion quattro extraction balloon appeared to kink up on the wire and the balloon broke while using.Device retrieved from patient and another balloon was used.

• Brand Name: FUSION QUATTRO EXTRACTION BALLOON
• Type of Device: CATHETER, BILIARY, SURGICAL
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 13470655
• MDR Text Key: 285173745
• Report Number: 13470655
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G48225
• Device Catalogue Number: FS-QEB-A
• Device Lot Number: W4533973
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/25/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32850 DA
• Patient Sex: Female