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	G13768
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a percutaneous transhepatic cholangial drainage (ptcd) procedure, the hub detached from an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter.The device was placed with the seldinger technique to drain bile from the gallbladder of a bed bound patient.After the hub separation, another catheter was obtained to complete the procedure.It was noted that the device was stored hanging from a shelf.No damage to the packing was observed prior to use.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
D2a - common device name: additional names: gbo catheter, nephrostomy, general & plastic surgery; lje catheter, nephrostomy.D2b - procode: additional product codes: gbo, lje.E1 - customer (person): phone: (b)(6).H3 - device evaluated by mfg? device not 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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation it was reported that during a percutaneous transhepatic cholangial drainage (ptcd) procedure, the hub detached from an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter.The device was placed with the seldinger technique to drain bile from the gallbladder of a bed bound patient.After the hub separation, another catheter was obtained to complete the procedure.It was noted that the device was stored hanging from a shelf.No damage to the packing was observed prior to use.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of the documentation including the complaint history, device history record, quality control procedures and manufacturing instructions of the device, were completed during the investigation.The complaint device was not returned for evaluation; therefore, a physical examination could not be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that inspection activities are currently in place to prevent the release of nonconforming product related to the reported failure mode.A review of the device history record (dhr) found relevant quality control discrepancies, in which all affected devices were scrapped prior to further processing.It should be noted that there were no other complaints associated with the final product lot number.The manufacturer does not apply an ifu for this product.Instructions for use are applied by the local distribution partner.Evidence provided by a review of the dmr and dhr, suggests that the device was not manufactured out of specification and that there are no nonconforming devices in-house or out in the field.Based on the information provided, no returned product, and the results of this investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the event.The user did not report any damage during the initial placement.While it is possible that the catheter experienced excessive force or tension while in the patient, this cannot be confirmed.Per the risk assessment no further action is required.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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 or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• 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: 22912989
• Report Number: 1820334-2025-01075
• Device Sequence Number: 21109848
• Product Code: FGE
• UDI-Device Identifier: 00827002137684
• UDI-Public: (01)00827002137684(17)280514(10)16601136
• Combination Product (Y/N): N
• 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): 01/30/2026

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: G13768
• Device Catalogue Number: ULT7.0-35-25-P-5S-CLDM-WF-HC
• Device Lot Number: 16601136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2025
• 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
• Patient Sex: Unknown