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	G11020
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that suture of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter broke.During an unknown procedure, the mac-loc hub assembly was held firmly with one hand while the locking suture was pulled backwards with the other hand to form the pigtail loop at the distal end of the catheter.No "obvious jamming" was experienced when pulling the suture and pushing down the locking lever.Upon applying additional force, the suture broke.Another drainage catheter from a different lot was used to successfully complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Upon inspection of the returned catheter, cook discovered the catheter tip was torn, thus prompting this report.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.D2a- additional common names: gbo catheter, nephrostomy, general & plastic surgery; lje catheter, nephrostomy.D2b- additional product codes: gbo; lje.E1 - phone number: (b)(6).H3 - device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.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.

• 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 Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; +1(812)339-2235
• MDR Report Key: 50889046
• Report Number: 1820334-2026-00999
• Device Sequence Number: 9791541
• Product Code: FGE
• UDI-Device Identifier: 00827002110205
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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 Model Number: G11020
• Device Catalogue Number: ULT7.0-35-25-P-5S-CLDM-HC
• Device Lot Number: 17002979
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/22/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2026
• 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