MAUDE Adverse Event Report: COOK INC ULTRATHANE COPE NEPHROURETEROSTOMY SET; LJE CATHETER, NEPHROSTOMY

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

Reporter occupation: lead ir tech.Pma/510(k) #: preamendment.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported a male patient required the use of an ultrathane cope nephroureterostomy set for a bilateral drain tube exchange procedure.The operator reported placing the new drain utilizing a direct stick technique.After placement , the device was reported to be secured using a "statlock" device.Approximately ten minutes after the procedure was completed the tech was connecting the device to drainage when the hub separated from the catheter.The tech "called the physician back to the procedure area and he visually inspected the drain and they were not able to reattach the hub onto the drain of the catheter." the device was removed and another similar device was successfully placed in the patient.No other adverse effects were reported for this incident.

Manufacturer Narrative

D10 ¿ product received on: 18feb2020.Investigation ¿ evaluation: an ir technician from (b)(6) informed cook of an incident involving a ultrathane cope nephroureterostomy set.On (b)(6) 2020, the tubing separated near the hub post procedure.An additional procedure took place to replace the device.No unintended section of the device remained inside the patient¿s body and there have been no other adverse effects to the patient due to this occurrence.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection, were conducted during the investigation.The complainant returned one used ult catheter for investigation.Physical examination of the returned device showed biomatter present throughout the device.The hub was returned separated from the tubing.The tubing was separated with the flare missing from the tubing.The cap and mac-loc were disassembled and the flare was not in the cap.At this time, cook cannot conclude that the device was manufactured out of specification.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits.Product labeling was also reviewed.The product instructions for use (ifu) provides the following information to the user related to the reported failure mode: how supplied: ¿upon removal from package, inspect the device to ensure no damage has occurred.¿ a review of the device history record (dhr) was also conducted as a part of the investigation.The dhr for the complaint lot and related subassembly lots revealed no relevant non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.At this time, cook could not conclude that nonconforming product from this lot exists in house or in the field.Based on the information provided, the examination of the returned product, and the results of the investigation, it was concluded that a component failure without a manufacturing or design deficiency contributed to this incident.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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 COPE NEPHROURETEROSTOMY SET
• Type of Device: LJE CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9741776
• MDR Text Key: 192671487
• Report Number: 1820334-2020-00418
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00827002481763
• UDI-Public: (01)00827002481763(17)221111(10)10142229
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

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: 11/11/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-24-NUCL-B-RH
• Device Lot Number: 10142229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: 04/21/2020
• Supplement Dates FDA Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention