MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a (b)(6) male patient underwent a procedure in which an ultrathane mac-loc locking loop multipurpose drainage catheter was placed for nephrostomy drainage of the right kidney.The drain was noted to be leaking "since insertion" and an unsecure connection was discovered between the hub and the catheter tubing.The device was removed and replaced without adverse effects to the patient.
Additional Manufacturer Narrative
Occupation: patient safety analyst.Pma/510(k) #: exempt.A follow up report will be submitted should additional relevant information become available.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.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, 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
In additional information, it was reported that the device was leaking for 3 days before it was replaced.
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.It was reported by megan rudy of m.S.Hershey medical center (united states) that on 19sep2021 an ultrathane mac-loc locking loop multipurpose drainage catheter (rpn: ult12.0-38-25-p-6s-clm-rh; lot#: 14063664) leaked.The device was required for a nephrostomy drain and was placed in the patient¿s right kidney.After insertion leakage was noted.Three days later, surgical intervention was required to replace the device to prevent permanent impairment.Additional communication with the customer indicated that the leakage appeared to be coming from the hub and not the tubing.The suture string was not tied around the locking lever.No other adverse events were reported due to this occurrence.Reviews of the complaint history, device history record (dhr), quality control, specifications, and instructions for use (ifu) of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for the reported complaint device lot and related subassembly lots revealed no recorded non-conformances relevant to the failure mode.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The instructions for use (ifu) t_multi_rev5 supplied with the complaint lot were reviewed for information related to the reported failure mode.Per the ifu: ¿precautions¿ patients with indwelling drainage catheters should be evaluated routinely to essure continuous function of the catheter¿ instructions for use: 1.Under fluoroscopic control, perform standard techniques for placement of percutaneous drainage catheters, either by seldinger access or trocar access¿ how supplied ¿ upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the available information, no device return, and the results of the investigation, cook has determined the root cause is traced to 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 MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• 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: 13029027
• Report Number: 1820334-2021-02714
• Device Sequence Number: 11807163
• Product Code: GBO
• UDI-Device Identifier: 00827002095038
• UDI-Public: (01)00827002095038(17)240701(10)14063664
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2022

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: 07/01/2024
• Device Model Number: N/A
• Device Catalogue Number: ULT12.0-38-25-P-6S-CLM-RH
• Device Lot Number: 14063664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2021
• Supplement Date Received by Manufacturer: 11/23/2021; 08/26/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 08/19/2022; 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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 Age: 74 YR
• Patient Sex: Male