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

Model Number G48225

Device Problems Bent (1059); Material Frayed (1262); Kinked (1339); Difficult to Remove (1528); Torn Material (3024)

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

Event Date 04/09/2018

Event Type  malfunction  

Event Description

The patient was scheduled for an endoscopic retrograde choloangio-pancreatography (ercp).Medical doctor had difficulty when attempting to pull guidewire out of the scope thru the balloon guidewire outlet.Medical doctor had to use force to remove guidewire.Guidewire, once removed, was noted to be bent and knotted up.Upon removal of cook fusion quatro extraction balloon, the guidewire outlet was noted to be torn with frayed edges.There seemed to be a tear in the balloon because of the guidewire.This device was being used in the patient and did inflate the balloon.Noticed this when trying to pull guidewire out of the scope.Patient was able to complete procedure.Used same scope but located a new wire and new balloon.

• Brand Name: FUSION QUATTRO
• Type of Device: CATHETER, BILIARY, SURGICAL
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7450411
• MDR Text Key: 106177032
• Report Number: 7450411
• Device Sequence Number: 1
• Product Code: FGE
• 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: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: G48225
• Device Catalogue Number: FS-QEB-A
• Device Lot Number: W4000596
• Other Device ID Number: WIRE NO. 34265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR