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 Leak/Splash (1354); Material Puncture/Hole (1504)

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

Event Date 07/19/2023

Event Type  malfunction  

Event Description

It was reported that an ultrathane mac-loc locking loop multipurpose drainage catheter leaked.During a drain exchange procedure, the catheter was placed in the patient over a 0.035 wire guide and was locked without any complication.Once the device was in place, it was discovered that the catheter was leaking from the hub.The catheter was then removed and replaced without complication.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

E1 - customer (person): phone: (b)(6).G4 ¿ 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.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 or that a death or serious injury occurred; nor is it admission 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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation: on 20jul2023 cook australia received a complaint from the (b)(6) hospital, located in the city of (b)(6).It was reported that upon the placement and locking the loop of an ultrathane mac-loc locking loop multipurpose drainage catheter (rpn: ult8.5-38-25-p-6s-clm-rh, lot 15456745), leakage was discovered from the mac-loc adaptor.The device was removed and replaced with a new drain without complication.Reviews of documentation including the complaint history, device history record (dhr), quality control, manufacturing instructions (mi), and instructions for use (ifu), as well as a visual inspection and functional test of the returned device were conducted during the investigation.One used catheter was returned to cook for evaluation.A functional test of the device confirmed leakage.Upon the dissembling the white connecting cap from the mac-loc adaptor, tears in the shaft of the catheter were discovered at approximately 4 and 5 mm, when measuring from the proximal end of the flare.Cook has concluded that the device was manufactured to specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhrs for the reported complaint device lot 15456745 and the related subassembly lots revealed two related non-conformances, one for "gap incorrect" and one for "flare inadequate" in which both devices was scrapped.A database search identified one other event reported for an unrelated failure mode.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The ifu (t_multi2_rev1, ultrathane mac-loc locking loop biliary drainage catheter) supplied with the device instructs that the product should be inspected prior to use to ensure no damage has occurred.Based on the information provided, inspection of the returned device, and the results of the investigation, cook medical has concluded the root cause category would fall under cause traced to component failure, without any design or manufacturing issue.The user did not identify any damage during initial placement.It is possible that the catheter underwent excessive force or tension while placed in the patient, though this cannot be confirmed without additional information.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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 or that a death or serious injury occurred; nor is it admission 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

The device was received by cook on 08aug2023.Upon initial investigation, a tear/hole in the catheter shaft, about 4mm from the catheter cap, was discovered.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5, d9, h6- annex a, annex g.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 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 or that a death or serious injury occurred; nor is it admission 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
• 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: 17373436
• MDR Text Key: 319620277
• Report Number: 1820334-2023-00951
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002095014
• UDI-Public: (01)00827002095014(17)260523(10)15456745
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2023

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: ULT8.5-38-25-P-6S-CLM-RH
• Device Lot Number: 15456745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/20/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 08/08/2023; 08/25/2023
• Supplement Dates FDA Received: 08/10/2023; 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2023
• 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
• Treatment: .035 AMPLATZ WIRE GUIDE.
• Patient Sex: Male