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

Model Number N/A

Device Problems Difficult to Remove (1528); Material Separation (1562)

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

Event Date 10/16/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: 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 mac-loc locking loop multipurpose drainage catheter for a drainage procedure.During the procedure, the stiffener was difficult to remove and got stuck.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Event Description

Additional information provided 29oct2020 and 11nov2020 stated the following: the procedure was a routine change of a bilateral ileal conduit drainage catheter.The device is placed "retrograde from stoma, along conduit, through strictured anastomosis to renal pelvis to drain urine safely to stoma bag." one side was exchanged without issue.The patient reportedly had standard anatomy, no tortuosity although stricture between ileal conduit and ureter at anastomosis was noted.There was no crusting on the existing drain.The device was prepped and no resistance was felt.The existing drain was removed over a sensor wire and the replacement device was advanced over the wire with no resistance.The operator then tried to remove the blue stiffener, and experienced significant resistance.The flexible stiffener snapped in the drain and the whole system including the wire had to be removed and disposed.Access was regained with some difficulty.Another device of the same lot was advanced into the target site without resistance.Difficulty was again experienced when trying to remove the blue stiffener, but eventually the stiffener was able to be removed.The procedure was successfully completed with the second device.The operator stated the screen time was much lengthier and the patient was anxious due to the additional time.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Additional information: b5, b7, e1, e3, d10, d11, h3, h6-method code.E3 -- occupation: sister, radiology department.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

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

Manufacturer Narrative

D10 ¿ product received on: 17nov2020.Investigation ¿ evaluation : bradford teaching hospital nhs trust in the united kingdom informed cook that on 16oct2020 the flexible stiffeners in 2 ultrathane mac-loc locking loop multipurpose drainage catheters were difficult to remove from the catheters.The user advanced the stiffener and catheter into the patient for routine ileal conduit drainage.The user experienced difficulty removing the stiffeners, and the hub separated on one of the stiffeners.The patient's anatomy was not tortuous and there were no abnormalities.A new drain was used to complete the procedure without adverse effects to the patient.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control of the device, as well as a visual inspection and dimensional verification, were conducted during the investigation.The customer returned one used and damaged flexible stiffener.The catheter was not returned for evaluation.The stiffener length is 88cm with approximately 63cm of elongation damage.The stiffener outer diameter was measured at an undamaged section.The outer diameter was within specification.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: "precautions: when inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture.How supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ a review of the device history record (dhr) was also conducted as a part of the investigation to check for failure related nonconformances and additional complaints.The dhr for the complaint lot and related subassembly lots found no related nonconformances.A review of complaint history found no additional complaints on the lot.There is no evidence of nonconforming material in house or in the field.A capa was previously opened to investigate this failure.The capa implemented corrective actions related to supplier manufacturing of the catheter tubing.The supplier lots for this complaint were manufactured prior to corrective action implementation.Based on the information provided, the examination of returned product, the results of the investigation, and the manufacture date of the supplied lot, it was concluded tat the cause of this event is related to supplier manufacturing.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.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.

• Brand Name: ULTRATHANE 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: 10750462
• MDR Text Key: 214373949
• Report Number: 1820334-2020-01953
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002097650
• UDI-Public: (01)00827002097650(17)230611(10)13239234
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2021

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: 06/11/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-45-P-6S-CLM-RH
• Device Lot Number: 13239234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 10/29/2020; 01/21/2021
• Supplement Dates FDA Received: 11/19/2020; 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC SENSOR WIRE; FLEXIMA APD CATHETER; ZIP WIRE