MAUDE Adverse Event Report: COOK INC ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial reporter also sent report to fda: unknown.Pma/510(k) #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported an unknown patient required placement of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter for a biliary drainage procedure.During the procedure, the operator noted "it was impossible" to remove the stiffener from the drainage catheter.The device was replaced with a new, similar device to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Additional information: d10- concomitant medical product received on: 04dec2019.Investigation-evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection, functional test, and dimensional verification, were conducted during the investigation.The complainant returned the complaint device in a used condition with the metal stiffener fully inserted through the catheter.Biological matter was noted to be present throughout the device.The metal stiffener was able to be removed when the distal end of the catheter was massaged.The stiffener was reinserted into the catheter and did not replicate the failure of becoming stuck.The catheter tubing was cut in order to measure catheter inner diameter.All relevant dimensions such as catheter inner diameter and metal stiffener outer diameter and length were measured within specification.Additionally, a document based investigation evaluation was performed.The device master record (dmr) was reviewed and has shown that sufficient controls are in place to detect this failure mode prior to release.The device history record (dhr) was also reviewed.The lot showed no nonconformances.Related catheter subassembly lot also showed no nonconformances.A database search revealed no other complaints from lot at the time of investigation.Since there are no related nonconformances or other complaints from this lot, there is no evidence that nonconforming product exists in house or in the field.Based on the information provided, the examination of returned product and the results of the investigation, a definitive cause could not be established.Appropriate measures have been taken to address this failure mode.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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 the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9444255
• MDR Text Key: 195043403
• Report Number: 1820334-2019-03066
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002123847
• UDI-Public: (01)00827002123847(17)221002(10)NS10056691
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

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 Expiration Date: 10/02/2022
• Device Model Number: N/A
• Device Lot Number: NS10056691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 12/16/2019
• Supplement Dates FDA Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1