MAUDE Adverse Event Report: COOK INC.; CATHETER, BILIARY, SURGICAL

Lot Number 7002343

Device Problem Cut In Material (2454)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/01/2016

Event Type  Injury  

Event Description

While removing a nephrostomy tube during a transplanted kidney nephrectomy after rejection last fall, the nephrostomy tube was cut as part of the procedure and the main part of the tubing was removed on the kidney side.A 4cm piece of the tubing that was in the bladder was not removed and thus retained in the patient.This was discovered during recent hospitalization on ct scan and it was removed yesterday.

• Type of Device: CATHETER, BILIARY, SURGICAL
• Manufacturer (Section D): COOK INC.; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6728534
• MDR Text Key: 80564506
• Report Number: 6728534
• 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: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Lot Number: 7002343
• Other Device ID Number: 16FR X 40 CM DRAINAGE CATHETE
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/14/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: DIALYSIS; GENERAL ANESTHESIA, CRAWFORD CLAMP, PROLENE SUTURE; IMMUNOTHERAPY
• Patient Outcome(s): Other
• Patient Age: 37 YR