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 Leak/Splash (1354); Material Split, Cut or Torn (4008)

Patient Problem No Code Available (3191)

Event Date 11/25/2020

Event Type  Injury  

Manufacturer Narrative

Occupation: unknown.Pma/510(k) #: exempt.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported an unknown patient required placement of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter for bile duct pus drainage.The device was placed on (b)(6) 2020 and no issues were detected.Five days later, a hospital staff member found that the catheter was torn and leaking.The device was removed and another similar device was placed successfully.No other adverse effects were reported for this incident.

Manufacturer Narrative

Investigation ¿ evaluation: marugame medical center (japan) informed cook that a ult8.5-38-25-p-5s-cldm-wf-hc (ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter) from lot 10073885 was torn after placement.The catheter was placed on (b)(6) 2020 during a bile duct drainage procedure.The user reported that there were no issues detected during or immediately after placement.Five days later, on (b)(6) 2020, a hospital staff member found the catheter was torn and leaking.The device was removed and another device was placed to continue treatment successfully.No other adverse events were reported during this incident.A review of documentation including the complaint history, device history record (dhr), instructions for use (ifu) and quality control, as well as a visual inspection of the returned device, was conducted during the investigation.One used ult was returned for evaluation.There was one partial cut or tear in the catheter tubing just below the connector cap.No additional damage was noted to the device.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that sufficient inspection activities are in place to identify the failure mode prior to distribution.A review of the design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the device history record (dhr) for lot 10073885 and catheter tubing lot sa10019145 found no related nonconformances that could have could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with this lot number.Based on the dmr review, device history record, device failure analysis, and dhf review, there is no indication the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Cook also reviewed product labeling.The instructions for use (ifu), provides the following information related to the reported failure mode: "precautions: patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter." based on the information provided, examination of the returned product, and the results of our investigation, it was concluded that the cause of this event was a component failure without design or manufacturing deficiency.It is possible that the catheter underwent excessive force or tension while placed in the patient, contributing to the failure mode.However, this cannot be confirmed without additional information.The appropriate personnel have been notified.Per the quality engineering 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.

Event Description

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

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.

• 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
• MDR Report Key: 10984370
• MDR Text Key: 220708101
• Report Number: 1820334-2020-02271
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2021

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 Expiration Date: 10/10/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-5S-CLDM-WF-HC
• Device Lot Number: 10073885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 12/02/2020; 04/08/2021
• Supplement Dates FDA Received: 04/06/2021; 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention