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 Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2a- additional common names: gbo catheter, nephrostomy, general & plastic surgery; lje catheter, nephrostomy.D2b- additional product codes: gbo; lje.E1 - initial reporter establishment name and address: (b)(6).E1 - phone number: (b)(6).H3 - device evaluated by mfg.? device evaluation anticipated but has not begun.Awaiting device return.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 that an 85-year-old male patient required replacement of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter.The drainage catheter was placed on (b)(6) 2025 for biliary tract drainage.The following day, (b)(6) 2025, the bile drainage was noted to be obstructed.The catheter was removed and replaced with a new same drainage catheter.The customer stated that upon flushing the catheter post-removal, a crack was noted in the drainage catheter.No other adverse effects were reported for this incident.
Event or Problem Description
The complaint device was returned to the manufacturer on 21oct2025.During the preliminary device failure analysis, it was found that the device was leaking from the hub, with the flare torn.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b5, d9 - date returned to mfg.Correction: h6 - annex a.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 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
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation: it was reported that an 85-year-old male patient required replacement of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter.The drainage catheter was placed on (b)(6) 2025 for biliary tract drainage.The following day, (b)(6) 2025, the bile drainage was noted to be obstructed.The catheter was removed and replaced with a new same drainage catheter.The customer stated that upon flushing the catheter post-removal, a crack was noted in the drainage catheter.No other adverse effects were reported for this incident.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 and functional test of the returned device, were conducted during the investigation.Cook received one device in an opened, used, and damaged condition.The catheter appeared to leak at the junction where the shaft meets the white cap and mac-loc adaptor.The cap/mac-loc adaptor connection site was within gap gauge specifications; however, visual inspection through the lumen of the mac-loc adaptor revealed that the flare was wrinkled.Based on these findings, cook has determined that 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 dhr for the reported complaint device lot recorded two relevant quality control discrepancies.A complaint history search identified no other events reported for the related failure mode.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook reviewed the product labeling for the complaint device.The instructions for use (ifu) [ t_multi2_rev1, multipurpose drainage catheter] states the following.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 medical has concluded that the main cause of failure is manufacturing related.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: 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: 23286247
• Report Number: 1820334-2025-01256
• Device Sequence Number: 8762062
• Product Code: FGE
• UDI-Device Identifier: 00827002110205
• UDI-Public: (01)00827002110205(17)280604(10)16629158
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K173035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2026

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: G11020
• Device Catalogue Number: ULT7.0-35-25-P-5S-CLDM-HC
• Device Lot Number: 16629158
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 10/21/2025; 02/10/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/05/2025; 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2025
• 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: 85 YR
• Patient Sex: Male
• Patient Weight: 70 KG