MAUDE Adverse Event Report: COOK INC ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	G51595
Medical Device Problem Codes	Fluid/Blood Leak (1250); Gas/Air Leak (2946)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2a: additional common device names: catheter, nephrostomy, general & plastic surgery; catheter, nephrostomy.D2b: additional product codes: gbo; lje.E1: phone: (b)(6).H3: device evaluated by mfg?: device evaluation anticipated but not yet begun.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 or Problem Description
It was reported, an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter leaked during renal cyst drainage in a patient of unknown age and gender.A 6.3f pigtail drain was inserted in the patient.During aspiration of the cyst fluid, the doctor observed a significant presence of air bubbles in the syringe, raising suspicion of a potential air leak in the drain.Due to this, the drain was removed and replaced with a new drain.This exchange procedure resulted in discomfort for the patient.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation ¿ evaluation: it was reported that an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter leaked during renal cyst drainage in a patient of unknown age and gender.A 6.3f pigtail drain was inserted into the patient.During aspiration of the cyst fluid, the doctor observed a significant presence of air bubbles in the syringe, raising suspicion of a potential air leak in the drain.Due to this, the drain was removed and replaced with a new drain.This exchange procedure resulted in discomfort for the patient.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures, as well as a visual inspection, functional test, and dimensional verification of the returned device, were conducted during the investigation.A total of five ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheters were returned; one was used and four were unopened.Tabletop testing confirmed that the used device was leaking from the cap hub connection site.A further examination discovered a folded flare to be present within the lumen of the mac-loc adaptor.The gap between the cap and mac-loc adaptor met the gap gauge requirement.The remaining devices were examined and confirmed to have been manufactured to specification with no evidence of leakage.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 all associated dhrs discovered one relevant recorded nonconformance.This one device was scrapped before further processing of the order.To date, a further search of our database records confirmed this to be an isolated complaint.Cook also reviewed product labeling.The current instructions for use [ifu__multi2_rev1] is packaged with this device.The product ifu states the following in consideration of the reported failure mode: pre-cautions: 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.After reviewing the device evaluation, it was determined that the device was manufactured out of specification.However, based on review of the dmr, ifu, and dhr, cook has concluded that there are no additional nonconforming devices either in-house or out in the field.Based on the information provided, inspection of the returned device, and the results of the investigation, cook has determined that the main cause of the event falls under a manufacturing issue.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
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• 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: 21572698
• Report Number: 1820334-2025-00239
• Device Sequence Number: 8272227
• Product Code: FGE
• UDI-Device Identifier: 00827002515956
• UDI-Public: (01)00827002515956(17)251027(10)15041446
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K173035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/27/2025
• Device Model Number: G51595
• Device Catalogue Number: ULT6.3-35-25-P-5S-CLDM-HC
• Device Lot Number: 15041446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown