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

Model Number	G09705
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "during normal use" the suture thread of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter broke.It is unknown how long the device was in place in the 60-year-old male patient prior to the suture breaking.It was said that this occurrence led to accumulation of fluid and blood, resulting in local swelling, that needed to be extracted.A new drainage catheter was placed.No other adverse effects were reported for this incident.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Additional Manufacturer Narrative
D2a- additional common names: gbo catheter, nephrostomy, general & plastic surgery; lje catheter, nephrostomy.D2b- additional product codes: gbo; lje.E1 - phone number: (b)(60.H3 - device evaluated by mfg.? it is unknown if device will be returned to manufacturer.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
This complaint no longer meets the definition of a reportable event.See h11.
Additional Manufacturer Narrative
This report is being sent to indicate the complaint event is not reportable.In additional information received 04jan2026, it was clarified that the suture broke during the placement procedure while attempting to form the loop configuration.The suture broke at the point of the mac-loc hub outside of the patient and did not require retrieval.The mention of "accumulation of fluid and blood" requiring extraction referred to the need to place a new catheter for drainage.The patient did not require an additional procedure or experience any adverse effects.There is no evidence to suggest a suture thread that breaks during the procedure or during the locking of the mechanism would be likely to cause or contribute to a death or a serious injury if the failure were to reoccur.Furthermore, there is no evidence that a cook device caused or contributed to a serious injury, as no life-threatening or permanently impairing injury took place, nor was intervention taken as a result of the device failure which would be required to prevent permanent impairment or damage to the patient.As such, the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, or reportable product malfunction of a cook device.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
• Common Device Name: FGE; 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: 23945999
• Report Number: 1820334-2026-00004
• Device Sequence Number: 10758223
• Product Code: FGE
• UDI-Device Identifier: 00827002097056
• UDI-Public: (01)00827002097056(17)280508(10)16592372
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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
• Operator of Device: Health Professional
• Device Model Number: G09705
• Device Catalogue Number: ULT8.5-38-25-P-5S-CLDM-HC
• Device Lot Number: 16592372
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: 01/04/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 01/06/2026
• Date Device Manufactured: 05/08/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male