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 Problem Leak/Splash (1354)

Patient Problems Urinary Retention (2119); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2021

Event Type  Injury  

Manufacturer Narrative

Product lot number: 14096276 or 14187607.Implant date: (b)(6) 2021.Explant date: (b)(6) 2021.Initial reporter occupation: risk manager.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 Description

It was reported a (b)(6), male patient had an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter placed in (b)(6) 2021 for left nephrostomy drainage.In (b)(6) 2021, leakage was noted resulting in decreased output.The patient returned to interventional radiology for the device to be removed and replaced.No other adverse effects were reported.

Event Description

In additional information it was reported that the device was originally placed on (b)(6) 2021 but because the catheter was not draining properly, it needed to be replaced on (b)(6) 2021.The patient experienced urinary retention due to this occurrence.It was confirmed that no unintended section of the device remain inside the patient¿s body.

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.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Correction: d9, h3 investigation ¿ evaluation it was reported by (b)(6) of (b)(6) hospital located in the united states that an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (rpn: ult10.2-38-25-p-5s-cldm-hc, lot# unknown) leaked.The device was placed in the left kidney on (b)(6) 2021 during a bilateral percutaneous nephrostomy (pcn) placement procedure.About a week after placement, on (b)(6) 2021, leakage resulting in decreased output and urinary retention was noted.The patient returned to interventional radiology and the catheter was removed and replaced.No other adverse events were reported for this occurrence.Reviews of the complaint history, instructions for use (ifu), manufacturing instructions, quality control procedures, 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 incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are currently in place to prevent the release of non-conforming product related to the reported failure mode.The risk specifications covering mac-loc drainage catheters includes hub separation as a potential failure mode.The identified risk controls include the manufacturing quality control checks and process validation.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.The customer did not provide a lot number for this device.Therefore, cook medical inc.Performed an expanded sales search for the reported device shipped to this customer but was unable to identify the complaint lot.As a result, cook medical inc.Was unable to review the device history record.There is no evidence to suggest the product was not manufactured to current specifications or that there are non-conforming products in the house or in the field.Based on the review of current documentation, cook has concluded that inspection activities are currently in place to prevent the release of non-conforming product related to the reported failure mode.Capa investigations were previously opened to address mac-loc leakage and hub separation respectively.Both capas concluded that manufacturing and quality control deficiencies caused the reported failures and implemented corrective actions.This change went into effect on 31jul2019.Unfortunately, since a lot number could not be verified, cook medical was unable to determine if the device was manufactured prior to the corrective actions being implemented.Cook also reviewed product labeling.The instructions for use (ifu) t_multi_rev5 supplied with the complaint rpn were reviewed for information related to the reported failure mode.Per ifu t_multi_rev5: ¿device description¿ when ordered with the suffix -hc, the distal part of the catheter, sideports included, has an aq hydrophilic coating¿ precautions¿ activate the hydrophilic coating¿ for best results, keep catheter surface wet during placement¿ catheters should be irrigated on a routine basis to ensure function¿ patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter¿ how supplied¿ upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, no product returned, and the results of the investigation, it was determined the root cause category would fall under cause traced to component failure, being defined as component failure without any design or manufacturing issue.Unfortunately, since a lot number could not be verified, cook medical was unable to determine if the device was manufactured prior to the corrective actions being implemented 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
• 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: 13108407
• MDR Text Key: 282897049
• Report Number: 1820334-2021-02746
• Device Sequence Number: 1
• Product Code: GBO
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2022

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 Model Number: N/A
• Device Catalogue Number: ULT10.2-38-25-P-5S-CLDM-HC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 02/11/2022; 09/19/2022
• Supplement Dates FDA Received: 02/20/2022; 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 63 KG