MAUDE Adverse Event Report: COOK INCORPORATED TRI-EX; CATHETER, BILIARY, SURGICAL

Model Number G26856

Device Problem Leak/Splash (1354)

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

Event Date 07/20/2021

Event Type  malfunction  

Event Description

Attempted to utilize stone extraction balloon in ercp (endoscopic retrograde cholangiopancreatography) case, slow balloon leakage noted upon attempted use.No harm caused to patient.New extraction balloon utilized; case completed.

• Brand Name: TRI-EX
• Type of Device: CATHETER, BILIARY, SURGICAL
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12245252
• MDR Text Key: 264073090
• Report Number: 12245252
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G26856
• Device Catalogue Number: TXR-8.5-12-15-A
• Device Lot Number: W4446010
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA