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 Problems Obstruction of Flow (2423); Material Deformation (2976)

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/29/2023

Event Type  malfunction  

Event Description

During the placement procedure for a cook ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter it was discovered that the catheter experienced ballooning near the tip of the catheter.An image was provided by the customer showing ballooning of the catheter.The device was in place for approximately 10 minutes.The fluid discharge was not smooth, so the catheter was removed.A visual inspection showed the ballooning of the catheter.The procedure was completed by using another new device.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

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.H6 - annex c: c0708 - blockage identified.Investigation - evaluation: on 02feb2023 cook china was notified by the distributor (b)(4) that, during the placement procedure for a cook ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter, it was discovered that the catheter experienced ballooning near the tip of the catheter.The device was in place for approximately 10 minutes.The fluid discharge was not smooth, so the catheter was removed.A visual inspection showed the ballooning of the catheter.The procedure was completed by using another new device.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, and instructions for use (ifu) of the device, were conducted during the investigation.The ult8.5-38-25-p-5s-cldm-hc, ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter, lot number 14685636 was returned in an opened, used and damaged condition.The complaint device was returned with the mac-loc adaptor having been cut away from the catheter shaft, with approximately 2.0 cm of the catheter material attached to the mac-loc adaptor.A further examination of the catheter confirmed a bump/swollen section in the catheter material at approximately 20.3 cm, when measuring from the cut end of the catheter.This section of damage had a length measurement of approximately 5 mm.The inner diameter of the catheter was measured and confirmed to be within specification.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 14685636 and the related subassembly lots found one relevant nonconformance, in which all affected devices were scrapped prior to further processing.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 ifu packaged with the device contains the following in relation to the reported failure mode: "precautions activate the hydrophilic coating, if present, by wetting the catheter with sterile water or saline.For best results, keep catheter surface wet during placement.How supplied upon removal from package, inspect the product to ensure no damage has occurred." evidence gathered upon a review of the dmr, dhr and ifu, suggests that there is no evidence all items in the lot or similar devices in house or in the field are non-conforming.Additionally, based on the information provided, and device evaluation, cook medical inc.Has concluded the device was manufactured to specification.This complaint has been confirmed based on the customers testimony, provided photo and device evaluation.Cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to the event.The customer reported that approximately 10 mins after placing, the discharge of fluid was not smooth.The catheter was removed and the problem was found under visual inspection.Although this cannot be confirmed, it is feasible to suggest that during the discharge of fluid the drainage catheter became occluded, resulting in the ballooning of the material.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 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.

• 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: 17498731
• MDR Text Key: 320812690
• Report Number: 1820334-2023-01057
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002097056
• UDI-Public: (01)00827002097056(17)250425(10)14685636
• 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
• Report Date: 08/10/2023

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: ULT8.5-38-25-P-5S-CLDM-HC
• Device Lot Number: 14685636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2022
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Weight: 62 KG