MAUDE Adverse Event Report: COOK INC ULTRATHANE EXTENDED LENGTH SIDEPORTS BILIARY DRAINAGE CATHETER; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	G13353
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
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- customer (person): postal code: (b)(6).Phone: (b)(6).Additional phone #: (b)(6).Mobile #: (b)(6).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 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 'ultrathane extended length sideports biliary drainage catheter' leaked just after placement.The leak was noted "at the hub where the catheter enters the hub".A new drain was placed immediately to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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
Additional information received 24may2024.The new device was in place in the bile duct for less than 1 minute when the leaking was discovered.The child only need to stay a bit longer anesthetized because the second drain needed to be fetched.The drain was changed over a 0.035 guidewire "instantly".The patient's outcome was "good, no problem".No additional interventions, procedures, or medications were administered.
Additional Manufacturer Narrative
Investigation ¿ evaluation: on 22may2024, it was reported that an 'ultrathane extended length sideports biliary drainage catheter leaked just after placement.The leak was noted "at the hub where the catheter enters the hub".A new drain was placed immediately to complete the procedure.The new device was in place in the bile duct for less than 1 minute when the leaking was discovered.The child only need to stay a bit longer anesthetized because the second drain needed to be fetched.The drain was changed over a 0.035 guidewire "instantly".The patient's outcome was "good, no problem".No additional interventions, procedures, or medications were administered.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, instructions for use, as well as visual inspection and functional test of the returned device, were conducted during the investigation.The ultrathane extended length sideports biliary drainage catheter was returned in an opened, unused and damaged.The cap / mac-loc adapter connection site passed the required gap gauge requirement.During tabletop testing, a leak test confirmed fluid escaping at the cap / mac-loc adaptor connection site.The investigation discovered a flap to be present when looking down the lumen of the mac-loc adaptor.Based on this discovery, it was determined 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 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 device found one relevant nonconformance that could have contributed to the reported failure mode.All nonconforming devices were scrapped prior to further processing.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling: 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.Evidence gathered upon review of returned device indicates the device was manufactured out of specification.However, review of the dmr and dhr showed no evidence that there are additional nonconforming devices in house or out in the field.Based on the information provided, examination of the returned product, and the results of our investigation, it was concluded that device was manufactured out of specification.Cook has concluded that a manufacturing and quality control deficiency contributed to the event.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 the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ULTRATHANE EXTENDED LENGTH SIDEPORTS BILIARY 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: 19396044
• Report Number: 1820334-2024-00719
• Device Sequence Number: 20771861
• Product Code: FGE
• UDI-Device Identifier: 00827002133532
• UDI-Public: (01)00827002133532(17)261107(10)15744319
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2024

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: G13353
• Device Catalogue Number: ULT10.2-38-40-P-CLBS-26-RH
• Device Lot Number: 15744319
• 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: 05/22/2024
• Supplement Date Received by Manufacturer: 05/24/2024; 07/29/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 05/29/2024; 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COOK AMPLATZ GUIDEWIRE 0.035.; TERUMO STIFF GUIDEWIRE 0.035.
• Patient Sex: Unknown