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 Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2022

Event Type  Injury  

Event Description

It was reported an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter leaked at the hub.A new drain was placed.Additional information regarding the event and patient outcome have been requested but are currently unknown.

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.

Event Description

In additional information provided on 29apr2022, it was confirmed that the patient did not experience any adverse effects due to this occurrence.It was later reported on (b)(6) 2022 that the drain was placed in the left kidney and used for urinary drainage.The access site was lower back left.Leakage was discovered eight days after placement.Patient anatomy was described as "straight." device coating was activated with nacl for 1 minute.The device was replaced in an additional procedure.

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.

Manufacturer Narrative

Investigation ¿ evaluation: it was reported by (b)(6) that on 26apr2022 an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (rpn: ult8.5-38-25-p-5s-cldm-hc; lot#: 14478947) leaked between the mac-loc hub and connector cap.The device was required for urine drainage to treat hydronephrosis.During the procedure, the catheter¿s hydrophilic coating was activated with saline (nacl) for one minute then the device was inserted into left kidney, via lower back access utilizing a cook needle and wire.Eight days after placement, the catheter leaked and was subsequently replaced.No other adverse effects were reported due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), instructions for use (ifu), quality control and specifications, as well as a visual inspection, functional test, and dimensional verification of the returned device, were conducted during the investigation.A section of the ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (rpn: ult8.5-38-25-p-5s-cldm-hc), including the mac-loc adaptor, was received in an opened and used condition.The investigation confirmed that the thread showing between the cap and mac-loc adapter connection site passed the required gap gauge requirement.During table-top testing, a leak test confirmed fluid escaping at the cap and mac-loc adaptor connection site.The cap and mac-loc adaptor were disassembled, discovering the presence of a crease and tear in the flare.Based on the investigation results, it was determined the device was manufactured 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 design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhrs for the reported complaint device lot (14478947) and the related subassembly lots revealed no non-conformances related to the reported failure.A database search identified no other event reported events for this failure mode.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field cook also reviewed product labeling.The ifu packaged with the device contains the following in relation to the reported failure mode: mac-loc drainage catheters instruct that the product should be inspected prior to use to ensure no damage has occurred.Based on the information provided, inspection of the returned device, and the results of the investigation, a definitive potential root cause has been traced to component failure due to manufacturing deficiency.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 patient/event information has been received since the previous medwatch report was sent.

• 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: 14250640
• MDR Text Key: 290548520
• Report Number: 1820334-2022-00670
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002097056
• UDI-Public: (01)00827002097056(17)250118(10)14478947
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2022

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: ULT8.5-38-25-P-5S-CLDM-HC
• Device Lot Number: 14478947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/26/2022
• Initial Date FDA Received: 04/29/2022
• Supplement Dates Manufacturer Received: 04/29/2022; 07/26/2022
• Supplement Dates FDA Received: 05/12/2022; 07/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2022
• 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: NEEDLE.; WIRE.
• Patient Outcome(s): Required Intervention