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 Problem Gas/Air Leak (2946)

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

Event Date 08/02/2022

Event Type  Injury  

Event Description

It was reported that an unknown patient required placement of the ultrathane mac-loc locking loop multipurpose drainage catheter.The physician observed an air leak in the locked catheter after placement.The catheter was replaced with a new like device in an additional procedure.No other adverse effects were reported for this incident.Additional information regarding event details has been requested but is currently unavailable.

Manufacturer Narrative

Occupation: supervisor.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.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.

Manufacturer Narrative

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

Additional information received on 13oct2022, it was reported that the device was placed in the kidney.The air leak was noted after placement of the catheter, and it was assumed that there was an issue in the locking mechanism.

Manufacturer Narrative

Investigation ¿ evaluation: it was reported by a representative of (b)(6) hospital (usa) that an ultrathane mac-loc locking loop multipurpose drainage catheter (rpn ult10.2-38-25-p-6s-clm-rh; lot#: 14409357) leaked.After the device was placed in the patient¿s kidney, an air leak was discovered.An issue with the locking mechanism was assumed.As a result, the patient required an additional procedure to remove and replace the device.No other adverse effects were reported for this incident.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures, as well as a visual inspection and functional test of the returned device, were conducted during the investigation.One device was received in used condition.The investigation confirmed there was one thread showing between the white cap / mac-loc adapter connection site, passing the required gap gauge requirement.During the initial investigation, a visual examination into the lumen of the mac-loc adaptor discovered a fold in the flare, resulting in the i.D.Of the mac-loc becoming partially obstructed.During leak testing, with the lever of the mac-loc adaptor in a down-ward position (locked), fluid was confirmed to be escaping at the white connecting cap and mac-loc adaptor site.After disassembling of the mac loc adaptor from the white connecting cap, the flare was discovered to be folded inward and torn.Based on the investigation results, it was determined the device was manufactured out of specification.Additionally, document-based investigation evaluation was performed.A review of the device master record (dmr) concluded sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the device history record (dhr).The dhr for lot 14409357 found one possible relevant non-conformance for "folded flare".This device was scrapped prior to further manufacturing process.There were no additional complaints on this lot.An expanded search was conducted and all lots manufactured by the same flaring operator and proximal assembly operator were reviewed.Six total complaints for leakage were identified and the corresponding lots were placed on stop ship.The information provided upon review of the returned devices suggests that the device was manufactured out of specification.Review of the dhr suggests that there are additional nonconforming devices in the field but not in house.Containment was performed on related lots.Cook also reviewed the product labeling for the complaint device.The instructions for use (ifu) [ t_multi_rev5, multipurpose drainage catheter] states the following.Precautions: patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter.How supplied: upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided, inspection of the returned device, and the results of the investigation, it was determined the flare was manufactured out of specification.The cause of this event is manufacturing deficiency.The appropriate responsible manufacturing department was issued a defect awareness training.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, 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 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: 15566592
• MDR Text Key: 301480505
• Report Number: 1820334-2022-01609
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002095021
• UDI-Public: (01)00827002095021(17)241210(10)14409357
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-25-P-6S-CLM-RH
• Device Lot Number: 14409357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/07/2022
• Supplement Dates Manufacturer Received: 10/13/2022; 03/17/2023
• Supplement Dates FDA Received: 10/14/2022; 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2021
• 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