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

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Fistula (1862); Bowel Perforation (2668)

Event Date 08/03/2021

Event Type  Injury  

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.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

It was reported that an ultrathane mac-loc locking loop multipurpose drainage catheter migrated through bowel.The device was required for a study procedure ((b)(4)) and was placed in the right hemiabdomen for abscess drainage on (b)(6) 2021.Prior to the drain placement, dilation was performed.Computed tomography (ct) was used for visual guidance and the device was successfully placed and drainage was established.Five days post procedure, it was discovered that the drain had migrated through the bowel (anastomotic dehiscence/fistula).The device was removed and replaced on (b)(6) 2021.No other adverse effects were reported for this incident.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation on (b)(6) 2022, (b)(6) (usa) reported to cook research inc.That an ultrathane mac-loc locking loop biliary drainage catheter (rpn: ult8.5-38-25-p-6s-clm-rh; lot#: 13998660) migrated through bowel.The device was required for a study procedure mdr-1919 and was placed in the right hemiabdomen for abscess drainage on (b)(6) 2021.Prior to the drain placement, dilation was performed.Computed tomography (ct) was used for visual guidance and the device was successfully placed and drainage was established.Five days post procedure, it was discovered that the drain had migrated through the bowel (anastomotic dehiscence/fistula).As a result, surgical intervention was required to replace the device on (b)(6) 2021.No other adverse effects were reported for this incident.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, manufacturing instructions (mi), and instructions for use (ifu) 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.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 13998660 and the related catheter shaft sub-assembly lot sa13841829 revealed no related non-conformances.To date, a further search of our database records revealed no additional complaints received that was associated with the reported lot.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook reviewed the product labeling for the complaint device.The instructions for use (ifu) [ t_multi_rev5, multipurpose drainage catheter] packaged with the device contains the following in relation to the reported failure mode: how supplied: upon removal from package, inspect the product to ensure no damage has occurred.Intended use: multiple drainage catheters are intended for percutaneous drainage applications (e.G nephrostomy, biliary and abscess), either by direct stick or seldinger access technique.Warnings: if a catheter has become malposition or if drainage ceases, the catheter should be promptly exchanged or removed.References: these instructions for use are based on experience from physicians and (or) their published literature.Refer to your local cook sales representative for information on available literature.Based on the information provided and the results of the investigation, cook medical has concluded the root cause category would fall under cause not established.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.4.Admin.

Event Description

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

• Brand Name: ULTRATHANE 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: 14959497
• MDR Text Key: 295598934
• Report Number: 1820334-2022-01177
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002095014
• UDI-Public: (01)00827002095014(17)240601(10)13998660
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

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: 06/01/2024
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-6S-CLM-RH
• Device Lot Number: 13998660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 11/29/2022
• Supplement Dates FDA Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 57 KG