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); Migration (4003)

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

Event Date 09/13/2022

Event Type  Injury  

Manufacturer Narrative

Occupation: unknown.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 that an ultrathane mac-loc locking loop multipurpose drainage catheter leaked.After the device was placed for abscess drainage, leakage from the catheter was noted.The locking loop suture loosened, which possibly caused the drain to move forward in the patient.As a result, the patient returned to the hospital on (b)(6) 2022 for an additional procedure to remove and replace the device.No other adverse effects were reported for this incident.Additional information regarding event details has been requested, but is currently unavailable.

Event Description

In additional information received on 20sep2022, it was reported that leakage occurred from the drain hole most distal from the tip after the patient left the hospital.The device was placed in the parenchyma of the kidney via direct stick.No issues were noted during the procedure.

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

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

On 14sep2023 a representative of (b)(6) reported that an ultrathane mac-loc locking loop multipurpose drainage catheter (rpn: ult10.2-38-25-p-6s-clm-rh; lot#: 14867546) leaked.The device was placed via direct stick in the renal parenchyma for drainage, then the patient was discharged from the hospital.Later, leakage from the ¿drain hole most distal from the tip¿ was noted.It was reported the locking loop suture loosened, which possibly caused the drain to move forward in the patient.As a result, the patient returned to the hospital on (b)(6) 2022 for an additional procedure to remove and replace the device.No other adverse effects were reported for this incident.Reviews of documentation including the complaint history, device history record (dhr), instructions for use (ifu), quality control procedures, 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.The mac-loc adaptor was received cut off from the catheter with a small section of the catheter shaft attached to the mac-loc.The suture string was verified to be anchored between the cap and adaptor.The locking lever was confirmed to be in working condition.A leak test confirmed no fluid escaping from the locking lever or at the cap / mac-loc connection site.A visual examination of the separated section with sideports did not find any additional holes, nicks and or tears in the shaft.Additionally, there was no observed damage to the distal portion of the catheter shaft in the area described by the user where the leakage was noted.Based on the altered condition of the returned device, our testing was limited in an attempt to replicate the customers difficulty.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 14867546 revealed one related non-conformance for "hole in material" which was scrapped prior to further processing.To date, a further search of our database records revealed no complaints received associated with this lot.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 the device was manufactured to current specification.Cook also reviewed product labeling.The supplied ifu [ [t_multi_rev5] with the mac-loc drainage catheters instruct 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, the cause of event was determined to be a component failure, unrelated to design or manufacturing deficiencies.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: 15455274
• MDR Text Key: 300235761
• Report Number: 1820334-2022-01506
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002095021
• UDI-Public: (01)00827002095021(17)250729(10)14867546
• 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: 02/24/2023

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: 14867546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 09/20/2022
• Supplement Dates Manufacturer Received: 09/20/2022; 02/13/2023
• Supplement Dates FDA Received: 09/28/2022; 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2022
• 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): Required Intervention