MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	G09504
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2a - common device name: additional names: gbo catheter, nephrostomy, general & plastic surgery; lje catheter, nephrostomy.D2b - product code: additional product codes: gbo, lje.G4 - pma/510(k) #: k173035.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
It was reported that an ultrathane mac-loc locking loop multipurpose drainage catheter leaked where the catheter met the hub during an unspecified procedure on a patient of unspecified age and gender.On (b)(6) 2024, during the procedure, the physician observed leakage at the catheter hub and replaced it successfully with another like-device.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.However, 10 days later on (b)(6) 2024, the patient returned to the hospital due to catheter leakage.Another physician examined the patient and found that the hub had separated from the catheter.The complaint device was removed and replaced with a new like-device in an additional procedure.The user noted that no force was exerted on the catheter, as it was used normally.The drain was placed in the pelvis.This report captures hub leakage that occurred on (b)(6) 2024.The instance of hub separation that occurred on (b)(6) 2024 is captured in the report with patient identifier (b)(6).
Event or Problem Description
In additional information received on 31oct2024, it was reported that the hub had separated from the catheter.The hub had already separated when leakage was noted.An abscess was being drained at the time of failure.A drainage bag was attached to the catheter.All catheters get sutured and bandaged with 4 x 4 gauze and a transparent film dressing.
Additional Manufacturer Narrative
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 unknown, unchanged or unavailable.Investigation ¿ evaluation it was reported that during an abscess drainage procedure, an ultrathane mac-loc locking loop multipurpose drainage catheter separated at the hub and subsequently leaked.A new like device was used to complete the procedure.A drainage bag was attached to the catheter.All catheters are secured with suture and bandaged with 4x4 gauze and a transparent film dressing.The customer noted that no force was exerted on the catheter.Ten days later, the failure occurred again, so the patient returned for an additional procedure to remove and replace the device.This report will focus on the first device that separated during the procedure.The second device is capture in mdr 1820334-2024-01443.Reviews of the documentation, including the complaint history, device history record, instructions for use (ifu) for the device, quality control procedures, as well as a visual inspection and specifications of the returned device, were conducted during the investigation.One used catheter was returned to cook for evaluation.Upon visual inspection, it was noted the catheter shaft was separated from the 14fr.Mac-loc adaptor.Additionally, a small section of the shaft, including the flare, was separated from the other portion of the catheter shaft.No material was found to be between the cap and adapter.The distance between the cap and the hub was measured and determined to be within specification.A section of the flare exhibited a tear, with evidence of material elongation.Cook has concluded that there is no evidence to suggest that product 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 currently in place to prevent the release of non-conforming product related to the reported failure mode.A review of the device history record (dhr) for the reported complaint device found one relevant nonconformance for "flare incorrect, not seated correctly" in which 8 devices were scrapped.A complaint history search identified no other events reported for a 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 also reviewed product labeling.The ifu [ t_multi2_rev1, multipurpose drainage catheter] packaged with the device contains the following in relation to the reported failure mode: "precautions 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." based on the information provided, inspection of the returned device, and the results of the investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the reported event.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 MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• 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: 20589575
• Report Number: 1820334-2024-01442
• Device Sequence Number: 15085161
• Product Code: FGE
• UDI-Device Identifier: 00827002095045
• UDI-Public: (01)00827002095045(17)270627(10)16129807
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2025

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 Model Number: G09504
• Device Catalogue Number: ULT14.0-38-25-P-6S-CLM-RH
• Device Lot Number: 16129807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 10/31/2024; 01/23/2025
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 11/11/2024; 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• 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