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

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).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.
Event or Problem Description
It was reported a patient required placement of a drainage catheter from an ultrathane multipurpose drainage set for a biliary drainage procedure.Approximately a week after the device was placed in the patient's bile duct via seldinger technique with "an approach from body surface", drainage (aspiration) was unable to be completed and damage was noted from the suture area of the catheter.The device was confirmed to have leaked.As the physician attempted to exchange the catheter with another, it separated.Consequently, a competitor device was placed.No other adverse effects to the patient were reported.
Additional Manufacturer Narrative
Investigation ¿ evaluation: on 26may2021, cook japan received a complaint from a representative from (b)(6) hospital, located in the city of (b)(6).It was reported, during use the of the supplied ult8.5-38-25-p-5s-cldm-hsc-hc catheter within the ultrathane multipurpose drainage set, the catheter leaked and ultimately separated from the proximal fitting.A competitor¿s device was placed to continue treatment of the patient.A review of the complaint history, device history record, drawing, instructions for use (ifu), quality control procedures, and specifications of the device, as well as a visual inspection of the returned product, were conducted during the investigation.Only a section of the supplied dawson mueller catheter was returned in an opened, used and damaged condition.The proximal mac-loc fitting was not returned.Additionally, a document based investigation evaluation was performed.A device master record (dmr) review was performed, including quality control (qc) procedures and ifu information.The risk specifications covering mac-loc drainage catheters includes hub separation as a potential failure mode.The identified risk controls include the manufacturing quality control checks and process validation.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.The dhr for the listed lot records found one possible relevant non-conformances.This device was scrapped prior to further manufacturing process.To date, a further search of our database records revealed this complaint to be the only reported complaint associated with the complaint lot number.Since there is objective evidence the dhr was fully executed, and there are no other lot-related complaints that have been received from the field, cook medical inc.Has concluded that device was manufactured to current specification.There is no evidence that non-conforming product exists in house or in the field.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: how supplied: "upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, the examination of returned product and the results of the investigation, the cause was traced to a component failure.The appropriate internal personnel have been notified.Per the risk assessment, no further action is required.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 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: 11977968
• Report Number: 1820334-2021-01495
• Device Sequence Number: 3388214
• Product Code: GBO
• UDI-Device Identifier: 00827002272989
• UDI-Public: (01)00827002272989(17)240224(10)13646609
• 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): 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/24/2024
• Device Model Number: N/A
• Device Catalogue Number: CLDM-8.5-MH
• Device Lot Number: 13646609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown