MAUDE Adverse Event Report: COOK INC ULTRATHANE COOK-COPE TYPE LOCKING LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

Report received via medsun report (b)(4) : "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." original intended procedure: left-sided transplant nephrectomy with nephrostomy tube removal." instructions for use that accompany each device provide instructions for the removal and exchange of the catheters.

Manufacturer Narrative

Additional information: the device was requested; however, it is not being released per the facility's risk management department at this time.Investigation - evaluation: a review of complaint history, device history record, documentation, instructions for use (ifu), and quality control data was conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.The manufacturing documents in place at the time of manufacture were reviewed and it was found that the device aspect in question was visually inspected by quality control and no notable gaps in production or processing controls were identified.The device history record for the complaint lot number was reviewed.No related non-conformances were identified.A search of our complaint records indicates that this is the only complaint on the lot number at the time of investigation.There is no evidence to suggest that this device was made out of specification.Based on the information provided by the customer, the nephrostomy tubing was cut during the surgical removal of the kidney and inadvertently left in the bladder.Therefore, the root cause was determined to be user technique.We will notify the appropriate personnel and continue to monitor for similar complaints.

• Brand Name: ULTRATHANE COOK-COPE TYPE LOCKING LOOP BILIARY DRAINAGE CATHETER
• Type of Device: GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6777555
• MDR Text Key: 82173167
• Report Number: 1820334-2017-02242
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002092051
• UDI-Public: (01)00827002092051(17)190527(10)7002343
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT16.0-38-40-P-32S-BCL-HC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2017
• Date Device Manufactured: 05/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR