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 Break (1069); Difficult to Remove (1528)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2023

Event Type  malfunction  

Event Description

It was reported that a patient required placement of an ultrathane mac-loc locking loop multipurpose drainage catheter.During placement of the catheter, the stiffener was difficult to remove from the catheter, and the suture thread broke.This happened with two different catheters of the same lot.Additional information regarding the event and patient outcome has been requested but is currently unavailable.Two other incidents of difficult stiffener removal for this patient have been captured in reports with patient identifier: (b)(6).

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Occupation: ir lab manager, 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

It was reported in additional information that the patient did not experience any adverse effects or require additional procedures due to this occurrence.The physician was able to complete the procedure using new inventory/fresh drain.Clarification was received that the rigid stiffener was utilized during the drain placement procedure.

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 unchanged, unknown, or unavailable.Investigation, evaluation.On 06mar2023, cook medical inc.Received a complaint from a representative of (b)(6) medical center.They report that the black suture strings to two ultrathane mac-loc locking loop multipurpose drainage catheter (rpn: ult12.0-38-45-p-6s-clm-rh; lot: 15148062) broke during locking, resulting in difficulty removing the stiffeners.The patient did not experience any adverse effects or additional procedures due to these events.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 dimensional verification of the returned device, were conducted during the investigation.Two devices were returned in a used and damaged condition.Both catheters exhibited suture string breakage.The investigation confirmed the suture string was anchored between the cap and mac-loc adaptor.A dissection of the catheter was performed, verifying the i.D.Measurements and confirming them to be within specification.Since the mentioned stiffeners were not returned, the investigation was unable to confirm the customer's difficulty regarding removal from the catheters.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that adequate inspection steps are currently in place to address this failure prior to distribution.Cook also reviewed the device history record (dhr).The dhr for lot 15148062 recorded no nonconformances relevant to the reported difficulty.To date, a further search of our database records revealed this complaint to be the only reported complaint associated with the complaint lot number.Cook also reviewed product labeling.The instructions for use [t_multi2 rev1] supplied with this lot state the following: precautions.When inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture.A tfe-coated wire guide must be used with ultrathane catheters.Instructions for use.Unlocking catheter loop.For mac-loc locking loop mechanism: a.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.B.Pry upward until the locking cam lever is free.(fig.4) how supplied.Upon removal from package, inspect the product to ensure no damage has occurred.The information provided upon review of the dmr, dhr, ifu, and returned device suggests that the device was manufactured to 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 root cause category would fall under cause 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.

• 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: 16620616
• MDR Text Key: 312315058
• Report Number: 1820334-2023-00320
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002097674
• UDI-Public: (01)00827002097674(17)260105(10)15148062
• 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: 07/28/2023

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: ULT12.0-38-45-P-6S-CLM-RH
• Device Lot Number: 15148062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 04/04/2023; 07/26/2023
• Supplement Dates FDA Received: 04/12/2023; 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2023
• 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