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 Detachment of Device or Device Component (2907)

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

Event Date 03/28/2023

Event Type  Injury  

Manufacturer Narrative

Initial reporter's occupation: interventional radiology 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.

Event Description

It was reported that an unknown patient required a replacement of an ultrathane mac-loc locking loop multipurpose drainage catheter.The drainage catheter was initially placed in the gallbladder of a "recurring patient" on (b)(6), 2023.Ten minutes after placement, the mac loc hub was discovered to be "detached" from the drainage catheter.The drain was reported to be securely connected to an extension tubing and a drainage bag.The device was successfully exchanged over a wire guide.No other adverse effects were reported for this incident.

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: it was reported by a representative of (b)(6) medical center ((b)(6), usa) that on (b)(6) 2023 an ultrathane mac-loc locking loop multipurpose drainage catheter (rpn: ult10.2-38-25-p-6s-clm-rh; lot#: 15165300) separated.The device was placed during an exchange procedure and was inserted over a wire guide into the gallbladder.The catheter was attached to an extension tube and drainage bag, and the fittings were noted to be securely attached.About 10 minutes after placement, the catheter separated near the mac-loc hub.As a result, the patient required an additional procedure to remove and replace the device.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, manufacturing instructions (mi), and instructions for use (ifu), as well as a visual inspection of the returned device, were conducted during the investigation.One catheter was returned in a used and damaged condition to cook for evaluation.The mac-loc adaptor was received separated from the shaft of the catheter.The point of separation appears to have been just below the mac-loc adaptor.Additionally, the proximal end of the shaft at the location of separation exhibited jaggedness and was missing the flare.Upon disassembling of the cap from the mac-loc adaptor, absence of the flare was noted.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 15165300 and the related subassembly lots revealed no related non-conformances.A review of complaint history for this lot found two additional complaints from the same customer for the same failure.To date, there have been no additional complaints received for leakage or hub separation from these lots.Additional related lots manufactured in a similar time period and lots made by the relevant operator were reviewed.No additional related complaints were noted from these lots.Some lots showed relevant nonconformances, but all nonconforming devices were scrapped prior to release.Since there are no related additional complaints received from the related lots, there is no evidence that additional nonconforming product exists in house or in the field cook also reviewed product labeling.The product ifu, [t_multi2_rev1] ¿multipurpose drainage catheter,¿ provides the following information to the user related to the reported failure mode: how supplied upon removal from package, inspect the product to ensure no damage has occurred.The information provided upon review of the dmr, ifu, dhr, and analysis of the returned device suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, inspection of the returned device, and the results of the investigation, cook medical has concluded the cause can be traced to component failure, without any design or manufacturing issue.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.

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 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 fitting was securely attached at first inspection.No issue was noted during the procedure.The patient was discharged after placement of the device.The patient's activity level is unknown.The activity level of two of the patients that experienced this failure with the device were free moving.The other patient's activity level was bed bound.

• 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: 16656698
• MDR Text Key: 312448146
• Report Number: 1820334-2023-00359
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002095021
• UDI-Public: (01)00827002095021(17)260116(10)15165300
• 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: 07/10/2023

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: 15165300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 03/31/2023
• Supplement Dates Manufacturer Received: 04/28/2023; 06/14/2023
• Supplement Dates FDA Received: 05/11/2023; 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2023
• 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
• Patient Outcome(s): Required Intervention