MAUDE Adverse Event Report: COOK INC ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; FGE CATHETER, BILIARY, DIAGNOSTIC

Catalog Number ULT8.5-38-25-P-5S-CLDM-HC

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

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

Event Date 10/27/2023

Event Type  malfunction  

Manufacturer Narrative

D2a- common device name: gbo catheter, nephrostomy, general & plastic surgery, lje catheter, nephrostomy d2b- product code: additional product codes: gbo, lje g4- pma/510(k) k173035 e1 - customer (person): address: (b)(6) 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 ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter leaked.During a nephrostomy procedure, a puncture was made, and the catheter was placed in the patient.An air leak in the catheter was suspected which prevented proper drainage.The leak was confirmed, so the catheter was removed and replaced with an identical device.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

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

Additional information was provided.As reported, the device was placed in the patient's kidney.The leakage occurred at the connection between the catheter and the catheter hub.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Correction: h6 - annex a investigation ¿ evaluation during the placement procedure, the ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was found to be leaking.The device was removed and replaced to complete the procedure.The patient reportedly experienced no adverse effects as a result of this incident.Reviews of the documentation, including the complaint history, device history record, instructions for use (ifu), quality control procedures and specifications, as well as a visual inspection and functional test of the returned device, were conducted during the investigation.One used catheter was returned for evaluation.The catheter shaft was found to be separated.A leak test confirmed the presence of a leak between the cap and catheter material.The gap gauge measurement was found to be within specification.Upon examination of the flare, it was found to be damaged and torn.The device was found to be out of specification due to the condition of the flare.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that controls are in place to detect this failure mode prior to release.A review of the device history record (dhr) for the device found no related nonconformances that could have contributed to the reported failure mode.It should be noted that no other complaints were associated with the final product lot number.Further investigation of related lots found two additional complaints for leakage, in which the affected lots with leakage complaints were placed on stop ship.Cook was also able to review product labeling.Instructions for use (ifu) document t_multi2_rev1 is packaged with this device.The product ifu states the following in consideration of the reported failure mode: ¿how supplied: upon removal from package, inspect the product to ensure no damage has occurred.¿ evidence provided upon review of the dhr and returned device suggests that the device was manufactured out of specification and that there are possible nonconforming devices in house or out in the field.Containment was performed on the complaint lot, but field action was determined not to be necessary.Based on the information provided, examination of the returned product, and the results of our investigation, it was concluded that a manufacturing deficiency at the supplier contributed to the reported event.The appropriate personnel have been notified.Per the risk assessment no further action is required.We will continue to monitor for similar complaints.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 DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Type of Device: FGE CATHETER, BILIARY, DIAGNOSTIC
• 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: 18161066
• MDR Text Key: 328416837
• Report Number: 1820334-2023-01590
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 00827002097056
• UDI-Public: (01)00827002097056(17)260103(10)15142802
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2024

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 Catalogue Number: ULT8.5-38-25-P-5S-CLDM-HC
• Device Lot Number: 15142802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 11/24/2023; 02/06/2024
• Supplement Dates FDA Received: 12/05/2023; 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2023
• 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 Age: 52 YR
• Patient Sex: Male
• Patient Weight: 78 KG