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); Obstruction of Flow (2423)

Patient Problem Pain (1994)

Event Type  malfunction  

Event Description

It was reported that an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter leaked while implanted in an unknown patient.Following placements on (b)(6) 2022, it was noted that drainage from the patient's dawson mueller catheter was low.At an unknown time in (b)(6), a leak was discovered at the entry site of the catheter into the skin.The patient was reportedly in pain when flow through the catheter was compromised.Flushing the catheter resolved the leak, however no visible stones were found.A nephrostogram performed on (b)(6) 2022 revealed that the tube was perfectly placed.The current tube is still in use by the patient, who will undergo a catheter exchange in march.No harm to the patient has currently been reported.Additional information regarding event details has been requested, but is currently unavailable.

Manufacturer Narrative

Occupation: gynecologist.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

Additional information was provided on 18mar2022.The patient had a left, unilateral nephrostomy tube.The device was placed via exchange over a wire.It was confirmed only one drain experienced leakage and it was noticed in january 2022 while the patient was sitting.The catheter was being exchanged regularly and the catheter is irrigated as needed or ordered by the urologist "as frequent as twice a day to once a week as needed." the catheter was connected to a nephrostomy bag that is changed weekly and urine was being drained through the line.The fitting was securely attached at first inspection.No force was exerted on the catheter.No adverse effects or additional procedures have been reported.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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.

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 patient and/or event details has been received since the previous medwatch report was sent.

Event Description

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

Manufacturer Narrative

Investigation ¿ evaluation on (b)(6)2022 cook medical received a complaint from (b)(6), a representative at the providence st.John's health ctr, located in the city of (b)(6).The patient had a left unilateral nephrostomy, using an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (rpn: (b)(64, lot: 14202807), being exchanged over a wire.A nephrostogram on january 31 revealed the drainage catheter was perfectly placed in the left kidney renal pelvis.A leak from the entry site of the drainage catheter at the skin was observed.The catheter was irrigated as needed or ordered by urologist "as frequent as twice a day to once a week as needed." the catheter was connected to a nephrostomy bag that is changed weekly.Urine was being drained through the line.The fitting was securely attached at first inspection.No force was exerted on the catheter.The patient did not experience any adverse effects due to this occurrence.Reviews of the documentation, including the complaint history, device history record, instructions for use (ifu), quality control procedures, as well of a visual inspection and functional test of the returned device, were conducted during the investigation.One ult12.0-38-25-p-5s-cldm-hc was received for evaluation in two sections.A functional test of the device was unable to confirm leakage from the cap/mac-loc body connection site, or the closed locking lever.The catheter passed the gap gauge requirement.Further investigation discovered the presence of an additional sideport that was placed in the shaft of the catheter at approximately 5.0cm when measuring from the distal end of the severed catheter containing the specified loop.It was concluded that this sideport was placed at the user facility.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient controls are in place to detect this failure mode prior to release.A review of the device history record (dhr) for lot 14202807 found no nonconformances that could have contributed to the reported failure.Catheter tubing lot sa14160166 was discovered to have one relevant nonconformance for ¿surface defect,¿ in which two devices were scrapped prior to further processing.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling.The instructions for use (ifu) [ t_multi_rev5, multipurpose drainage catheter] states the following."precautions -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." evidence gathered upon review of the dmr, ifu, dhr, design history file, and returned device, 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, examination of the returned product and the results of our investigation, it was concluded that a component failure without any design or manufacturing issue likely led to the reported event.The appropriate personnel have been notified.Per the 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.

• 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: 13724965
• MDR Text Key: 296078388
• Report Number: 1820334-2022-00379
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002104358
• UDI-Public: (01)00827002104358(17)240909(10)14202807
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/17/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT12.0-38-25-P-5S-CLDM-HC
• Device Lot Number: 14202807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2022
• Initial Date FDA Received: 03/10/2022
• Supplement Dates Manufacturer Received: 03/18/2022; 03/24/2022; 11/01/2022
• Supplement Dates FDA Received: 03/24/2022; 04/06/2022; 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2021
• 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