MAUDE Adverse Event Report: COOK INC; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 11/29/2022

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Customer (person): phone: (b)(6), occupation: unknown.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

It was reported an unknown multipurpose drainage catheter was difficult to remove during a routine replacement of the catheter.During a nephrostomy left external drain removal procedure, the physician had difficulty advancing the wire guide into the catheter for removal.Under imaging, a kink in the catheter was observed.After multiple attempts to advance the wire guide, the hub was cut off, and the wire guide finally advanced to allow removal of the catheter.A ureteric stent was then able to be placed.The physician does not believe the skin suture or kinking at the skin caused the issue.The physician believed the drain had a manufacturing fault.It was noted the device was secured to the skin with stiches.The stitches were distant to the kink, and the kink persisted after the stitches were cut.The clinician who initially placed the catheter did not indicate there were any issues with the catheter.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Correction: over the course of the investigation, it was discovered the cause of the catheter stricture was due to the 3-0 ethilon stitch suture used to secure the drain to the patient.The suture was tightened, and later became knotted around the shaft of the catheter while the device was in use.The failure was only identified when using imaging for a routine catheter replacement, as there were no known flow issues during use in the patient.This event is now considered not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury and/or product malfunction.There is no precedent of the failure, "catheter kink related to skin suture", leading to an ae, as a detailed search of risk documents and complaint history, have not indicated a previous event that has led to patient injury or harm.The patient did not experience any adverse effects due to this occurrence.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15944119
• MDR Text Key: 308188756
• Report Number: 1820334-2022-01828
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

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 Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/08/2022
• Supplement Dates Manufacturer Received: 03/03/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ETHILON SUTURE 3-0, MANUFACTURED BY ETHICON
• Patient Sex: Male