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

Model Number N/A

Device Problems Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2022

Event Type  Injury  

Event Description

It was reported a patient required replacement of an ultrathane amplatz universal drainage catheter.On (b)(6) 2022, the drainage catheter was initially placed without difficulty.The patient was described as active postoperatively.One week after placement, on (b)(6) 2022, a kink at the proximal side of the drainage catheter was found.The catheter was replaced with a new catheter successfully.No other adverse effects were reported for this incident.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Additional customer information: phone: (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.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.

Manufacturer Narrative

Investigation ¿ evaluation on 25jul2022, a representative of (b)(6) hospital (japan) reported to cook that an ultrathane amplatz universal drainage catheter (rpn: ult12.0-38-50-p-6s-audc-pig; lot#: 9968860) kinked.The device was required for a percutaneous transhepatic cholangiography (ptcd) procedure on (b)(6) 2022 and was placed in the patient without difficulty.About a week later, on (b)(6) 2022, a kink at the proximal side of the drainage catheter was observed.As a result, surgical intervention was required to replace the catheter to prevent permanent harm.No other adverse effects were reported.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, manufacturing instructions (mi), and instructions for use (ifu) of the complaint 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 dhr for the reported complaint device lot 9968860 and the related subassembly lots revealed no related non-conformances.To date, a further search of our database records found this to be the only complaint received involving the reported lot number.Since there is objective evidence the dhr was fully executed, cook medical inc.Has concluded there is no evidence the devices were manufactured out of specification, or that there are non-conforming devices in house or in the field.Cook also reviewed product labeling.The product ifu, t_multi_rev4, provides the following information to the user related to the reported failure mode: precautions: "a tfe-coated wire guide must be used with ultrathane® catheters " how supplied "upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, no product returned, and the results of the investigation, cook medical has concluded the cause to be 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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ULTRATHANE AMPLATZ UNIVERSAL DRAINAGE CATHETER
• Type of Device: 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: 15164121
• MDR Text Key: 297235988
• Report Number: 1820334-2022-01309
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002119758
• UDI-Public: (01)00827002119758(17)220823(10)9968860
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT12.0-38-50-P-6S-AUDC-PIG
• Device Lot Number: 9968860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/04/2022
• Supplement Dates Manufacturer Received: 03/07/2023
• Supplement Dates FDA Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention