MAUDE Adverse Event Report: COOK INCORPORATED COOK; CATHETER, NEPHROSTOMY

Model Number G09498

Device Problem Mechanical Jam (2983)

Patient Problem Failure of Implant (1924)

Event Date 01/25/2023

Event Type  malfunction  

Event Description

During the placement of a drainage catheter, the md was unable to remove the stiffener/stylet from the catheter.The catheter was removed, and a new catheter was placed without incident or harm to the patient.Manufacturer response for catheter, biliary drainage catheter 10.2 fr.40 cm (per site reporter).Per report, manufacturer notified.

• Brand Name: COOK
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 16551909
• MDR Text Key: 311402005
• Report Number: 16551909
• Device Sequence Number: 1
• Product Code: LJE
• 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: 02/27/2023

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 Model Number: G09498
• Device Catalogue Number: ULT10.2-38-40-P-32S-CLB-RH
• Device Lot Number: 15063991
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1