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 Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2023

Event Type  malfunction  

Event Description

It was reported the ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter leaked after a nephrostomy procedure to decompress the left kidney for 6 weeks for a 70 year-old, male patient.Complaints were received from the patient and ward about the device leaking after the procedure.The patient's urine had leaked continuously onto the bed and his clothes.A nephrostogram was performed to contrast check for leaks.The leakage was noted to be just proximal to the mac-loc.The patient was cleaned up and the site re-dressed.The patient was later returned to hith (hosp in home) and was told to use a bag and wafer (stoma bag) onsite to catch the fluid/leak.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1 - customer (person): postal code: (b)(6), phone: (b)(6) g4 - 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

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 unknown, unavailable, or unchanged.Correction: report reference information - date aware.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 or that a death or serious injury occurred; nor is it admission 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.

Manufacturer Narrative

Investigation ¿ evaluation.On (b)(6) 2023, (b)(6) radiology reported an issue with an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (ult8.5-38-25-p-5s-cldm-hc) from lot 15129359.After nephrostomy placement, the drain was noted to be leaking urine.The patient was instructed to use a stoma bag to catch the leak, and no other adverse effects were reported.Reviews of the complaint history, device history record (dhr), quality control, specifications, and instructions for use (ifu), as well as a visual inspection, functional test, and dimensional verification of the returned device, were conducted during the investigation.The complainant returned one used catheter as well as six sealed, unused devices from the same lot to cook for investigation of events with patient identifiers (b)(6) (mdr# 1820334-2023-00837), (b)(6) (mdr# 1820334-2023-00838), and (b)(6) (mdr# 1820334-2023-00841).It¿s unknown which event the used device is from, but it will be attributed to this report (patient identifier (b)(6), mdr# 1820334-2023-00837) for documentation purposes.The used device leaked during functional testing.The distance between the cap and mac-loc assembly was measured and was determined to be within specification.Visual inspection found the flare folded inward inside the hub.Based on the folded flare, the used device was determined to be out of specification.Additionally, 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 and the related subassembly lots revealed one related non-conformance for ¿flare inadequate - stiffener exited out cap¿ in which seven devices were scrapped.A database search identified two other events reported for the same failure mode, from the same customer.The catheter is supplied to cook.Additional lots manufactured by the same personnel as the complaint lot were reviewed.Further investigation of these lots found potentially related nonconformances, but no additional complaints from the field.Based on the available information, cook has concluded that there are possible nonconforming devices in the field.Containment was performed on related lots, but field action was determined not to be necessary.Cook also reviewed product labeling.Instructions for use (ifu) document t_multi2_rev1 is packaged with this device.The product ifu states the following in consideration of the reported failure mode: ¿how supplied: upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded a manufacturing deficiency at the supplier contributed to this incident.The appropriate personnel have been notified.Per the risk assessment no further action is required.Cook 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 or that a death or serious injury occurred; nor is it admission 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: 17218250
• MDR Text Key: 318071521
• Report Number: 1820334-2023-00837
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002097056
• UDI-Public: (01)00827002097056(17)251219(10)15129359
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2023

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: ULT8.5-38-25-P-5S-CLDM-HC
• Device Lot Number: 15129359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2023
• Initial Date FDA Received: 06/28/2023
• Supplement Dates Manufacturer Received: 06/28/2023; 10/09/2023
• Supplement Dates FDA Received: 06/29/2023; 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2022
• 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
• Treatment: 2L DRAINAGE BAG.; 3-WAY TAP.; DILATORS.; PERC NEEDLE.; WIRE.
• Patient Age: 70 YR
• Patient Sex: Male