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
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that leakage occurred from damage found between the shaft and hub of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter.The device was placed in the patient via abdominal approach for gallbladder drainage.After device placement, contrast media was found to be leaking from damage between the catheter and hub.The leaking device was removed and replaced with another device to complete the procedure.The patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the national cancer center in tokyo reported to cook on 22nov2021 that an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (ult7.0-35-25-p-5s-cldm-wf-hc) from lot 14199678 leaked after being placed for biliary drainage.The catheter was removed and replaced successfully.The patient reportedly experienced no adverse effects as a result of this incident.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.In response to this event, cook completed a review of the product device master record (dmr) and concluded that sufficient controls are in place to detect this failure mode prior to release.The device history record (dhr) of lot 14199678 showed no related nonconformances.A database search revealed four other complaints from lot 14199678 at the time of investigation.Three of these complaints concern the same failure mode.The information provided upon review of the dmr suggests that the device was not manufactured out of specification.However, review of the dhr suggests that there are nonconforming devices in house or out in the field.Containment was performed on the complaint lot, but field action was not considered based on occurrence.The ifu packaged with the device contains the following in relation to the reported failure mode: inspect the product upon opening to ensure no damage has occurred.Based on the information provided, no returned device, and the results of the investigation, it was determined the cause of this event is likely related to a manufacturing deficiency.Other devices from this lot exhibiting the same failure have been returned from other complaints and were confirmed to be manufactured out of specification.However, since the complaint device for this complaint was not returned, a physical examination of the device could not be performed and a manufacturing cause of failure could not be definitively confirmed.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 DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Common Device Name: 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: 12924418
• Report Number: 1820334-2021-02631
• Device Sequence Number: 4906439
• Product Code: GBO
• UDI-Device Identifier: 00827002137684
• UDI-Public: (01)00827002137684(17)240908(10)14199678
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2024
• Device Model Number: N/A
• Device Catalogue Number: ULT7.0-35-25-P-5S-CLDM-WF-HC
• Device Lot Number: 14199678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown