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 Inadequacy of Device Shape and/or Size (1583)

Patient Problem Failure of Implant (1924)

Event Date 08/10/2021

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.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 the patient underwent a study procedure (mdr 1919) to place a ultrathane mac-loc locking loop multipurpose drainage catheter on (b)(6) 2021 for abscess drainage in the perisplenic area.Later, it was discovered that the 8 french drain was too small to adequately drain the abscess.Therefore, the device was removed and replaced with a 10 french drain on (b)(6) 2021.No other adverse events were reported prior to the patient's exit from the study.

Manufacturer Narrative

Investigation ¿ evaluation: it was reported by cook research inc.Via baylor university medical center (usa) that an ultrathane mac-loc locking loop multipurpose drainage catheter (rpn: ult8.5-38-25-p-6s-clm-rh; lot#: 13998660) did not provide adequate drainage.The device was required on 10aug2021 during a study procedure (mdr 1919) to place a catheter for abscess drainage in the peri-splenic area.Prior to drain placement, dilation was performed, and ultrasound was used for visual guidance.The device was successfully placed, and drainage was successfully established.Later, it was discovered that the 8 french catheter was too small to adequately drain the abscess and complete fluid evacuation was not achieved.Therefore, surgical intervention was required to replace the device with a 10 french catheter on (b)(6) 2021.No other adverse events were reported prior to the patient's exit from the study.Reviews of documentation including complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures of the complaint 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.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 subassembly catheter shaft lot sa13841829 revealed no relevant non-conformances.To date, a further search of our database records revealed no additional complaints received that was associated with the reported lot.Cook also reviewed product labeling.The 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.Precautions¿ ¿ catheters should be irrigated on a routine basis to ensure function ¿ patients with indwelling catheters should be evaluated routinely to ensure continuous function of the catheter¿ 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.The information provided upon review of the dmr, ifu and the dhr suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, no product returned, and the results of the investigation, cook concluded the cause could not be 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.

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: 14939598
• MDR Text Key: 295404673
• Report Number: 1820334-2022-01162
• 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: 03/25/2023

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: 07/06/2022
• Supplement Dates Manufacturer Received: 02/28/2023
• Supplement Dates FDA Received: 03/25/2023
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 117 KG