MAUDE Adverse Event Report: COOK INC ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Gas/Air Leak (2946)

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

Event Date 09/27/2023

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1 - customer (person): address: (b)(6).G4 - 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 air leakage was identified at the hub of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter during an unknown procedure on a 65-year-old male patient.A percutaneous puncture of the biliary tract was done with the introducer and a 0.035 wire was exchanged into the biliary tract.The drainage catheter was advanced along the wire and successfully placed.A syringe was then used to extract bile; however, an air leak was identified at the hub of the catheter.The complaint device was then removed and replaced with a like device to complete the procedure.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Correction: h6 - annex g investigation ¿ evaluation on (b)(6) 2023 it was reported that, immediately following placement of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter into the biliary tract of the patient, a syringe was used to extract bile.However, it was noted that the catheter began to leak at the hub.The device was immediately removed and replaced, and 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.Upon a visual inspection, the flare was found to be folded inward inside of the hub.A functional test confirmed leakage at the hub.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient controls are in place to detect this failure mode prior to release.A review of the device history record (dhr) for the device lot found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the final product lot number.Further investigation of related lots found two additional complaints for the same failure.Affected lots with associated 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.¿ "when inserting a stiffening cannula into the catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of the suture." 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 a manufacturing deficiency at the supplier contributed to this incident.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.

Event Description

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

• Brand Name: ULTRATHANE DAWSON-MUELLER 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: 17853183
• MDR Text Key: 324719011
• Report Number: 1820334-2023-01318
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002097056
• UDI-Public: (01)00827002097056(17)251229(10)15139986
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

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 Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-5S-CLDM-HC
• Device Lot Number: 15139986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/02/2023
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2022
• 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
• Treatment: 0.035 WIRE; COOK HWAS-35-180; COOK NPAS-100-RH-NT
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 84 KG