MAUDE Adverse Event Report: COOK INC ULTRATHANE MULTIPURPOSE DRAINAGE SET; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: exempt.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 an ultrathane multipurpose drainage set leaked.The catheter was advanced into the bile duct using seldinger technique.Then, a leak between the hub and catheter tubing was discovered.The device was removed and replaced to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
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, unavailable, or unchanged.Investigation ¿ evaluation.On 28feb2022, a representative at the kita-harima medical center located in the city of hyogo jp reported to cook inc.Regarding the leakage of a ultrathane multipurpose drainage set (rpn: cldm-10.2-mh, lot: 14112729).The catheter was advanced using the seldinger technique into the bile duct of the patient.A leak between the hub and catheter tubing was discovered.The device was removed and was replaced with a new device to complete the procedure.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 (dhr), instructions for use (ifu), and quality control procedures of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examinations could be performed.However, a photo provided by the facility showed leakage at the catheter and mac-loc connection.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhrs for the reported complaint device lot 14112729 and the mac-loc subassembly lots sa14023136 and sa14061333 confirmed no relevant recorded nonconformances.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed the product labeling for the complaint device.The instructions for use (ifu) [ t_multi_rev5, multipurpose drainage catheter] states the following.How supplied: "upon removal from package, inspect the product to ensure no damage has occurred." the information provided upon review of the dmr, ifu and the 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, examination of a photos provided by the facility and the results of the investigation, cook concluded the root cause category would fall under cause traced to component failure, being defined as component failure without any design or manufacturing issue.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 MULTIPURPOSE DRAINAGE SET
• Common Device Name: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• 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: 13672935
• Report Number: 1820334-2022-00345
• Device Sequence Number: 17392218
• Product Code: GBO
• UDI-Device Identifier: 00827002300279
• UDI-Public: (01)00827002300279(17)240916(10)14112729
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2022

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: 09/16/2024
• Device Model Number: N/A
• Device Catalogue Number: CLDM-10.2-MH
• Device Lot Number: 14112729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2021
• 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