MAUDE Adverse Event Report: COOK INC ULTRATHANE MULTIPURPOSE DRAINAGE SET; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	G27298
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: b5 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
In additional information received on 11jun2024, it was reported that the device was in place for 15 minutes before leakage was noted.At the time of failure, the patient was lying on the operating table and hadn't moved.Patient activity level was described as "patient level is up with assist.".
Event or Problem Description
It was reported that the hub of the catheter from an ultrathane multipurpose drainage set was leaking.The device was required for a percutaneous transhepatic cholangio drainage (ptcd) procedure.After the leakage was noted, use of the device was discontinued.The physician used a new same device to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information regarding event details has been requested but is currently unavailable.
Additional Manufacturer Narrative
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).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
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.Correction: d4- model# investigation ¿ evaluation it was reported that the hub of the catheter from an ultrathane multipurpose drainage set was leaking.The device was required for a percutaneous transhepatic cholangio drainage (ptcd) procedure.After the leakage was noted, use of the device was discontinued.The physician used a new same device to complete the procedure.It was reported that the device was in place for 15 minutes before leakage was noted.At the time of failure, the patient was lying on the operating table and hadn't moved.Patient activity level was described as "patient level is up with assist.¿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, specifications, manufacturing instructions and instructions for use, as well as visual inspection and functional test of the returned device, were conducted during the investigation.The supplied, dawson-muller catheter from the ultrathane multipurpose drainage set, was returned in used condition.During table-top testing, using a syringe, hemostat, and water, it was confirmed water was escaping between the cap and mac-loc adaptor.A visual examination into the lumen of the mac-loc adaptor, confirmed the absence of a folded flare.The device passed the gap gauge test.No cracks were noted to the hub.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 nonconforming product related to the reported failure mode.A review of the device history record (dhr) for the device found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling: the product ifu states the following in consideration of 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.Evidence gathered upon review of the returned device indicates the device was not manufactured out of specification.A 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 a component failure unrelated to manufacturing or design deficiencies contributed to the reported 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.

• Brand Name: ULTRATHANE MULTIPURPOSE DRAINAGE SET
• 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: 19505027
• Report Number: 1820334-2024-00790
• Device Sequence Number: 7072835
• Product Code: FGE
• UDI-Device Identifier: 00827002272989
• UDI-Public: (01)00827002272989(17)260621(10)15445629X
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2024

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 Expiration Date: 06/21/2026
• Device Model Number: G27298
• Device Catalogue Number: CLDM-8.5-MH
• Device Lot Number: 15445629X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 06/11/2024; 09/04/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 06/17/2024; 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2023
• 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
• Patient Sex: Unknown