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 Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: ir director.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, 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

It was reported the suture string of an ultrathane mac-loc locking loop multipurpose drainage catheter was retained in a patient.The device was placed in the patient's abdomen for ascites drainage.Later, during removal of the catheter, the suture separated from the device and was retained in the patient.The physician attempted to retrieve the suture from the cavity but was unsuccessful.No other adverse effects were reported for this incident.

Manufacturer Narrative

Investigation - evaluation: on 16nov2022, it was reported by a representative of (b)(6) (united states) that the suture of an ultrathane mac-loc locking loop multipurpose drainage catheter (rpn: ult8.5-38-25-p-6s-clm-rh; lot#: 14979691) separated.The device was required for ascites drainage.During removal, a portion of the suture line separated from the catheter and was retained inside the patient¿s abdominal cavity.The physician attempted to probe the catheter insertion site for the retained suture, but the suture was not retrieved.No information regarding the patient was provided.It is unknown if the patient had difficult anatomy.The physician stated the patient was doing well.No other adverse events effects were reported due to this occurrence.Additional information regarding this event and patient outcome was requested but not provided.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), quality control procedures, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.In response to this incident, cook reviewed the device history record (dhr).The dhr for lot 14979691 confirmed one non conformance for "suture routed incorrect", having a quantity of 4, determined to be relevant to the reported difficulty.These devices were scrapped prior to further processing.The suture lot, 2260914.3 is supplied to cook by another manufacturer.There were no abnormalities recorded during the incoming inspection process, in addition to the supplier providing a certification of compliance, indicating the suture string met the required tensile strength requirement.To date, a further search of our database records revealed this complaint to be the only reported complaint associated with the complaint lot number.Since there is objective evidence the dhr was fully executed, and there are no other lot-related complaints that have been received from the field, cook has concluded that there is no evidence that non-conforming product exists in house or in the field and that device was manufactured to current specification.Cook also reviewed product labeling.The instructions for use [t_multi2_rev1] packaged with the device contains the following in relation 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.It is recommended to use a wire guide when removing a locking loop catheter.Instructions for use: unlocking catheter loop.For mac-loc locking loop mechanism: while stabilizing the mac-loc catheter hub assembly with one hand, position a small, blunt object (approximately the shape and size of a ball point pen or small forceps) into the mac-loc release notch.Pry upward until the locking cam lever is free.How supplied: upon removal rom package, inspect the product to ensure no damage has occurred.Based on the information provided, no returned device, and the results of the investigation, it was determined the cause of this event is related 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.

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: 15852386
• MDR Text Key: 304191710
• Report Number: 1820334-2022-01763
• Device Sequence Number: 1
• Product Code: GBO
• 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
• Report Date: 05/09/2023

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: ULT8.5-38-25-P-6S-CLM-RH
• Device Lot Number: 14979691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• 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): Other