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

Catalog Number ULT8.5-8.5-24-NUCL-B-RH

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) #: preamendment.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 during the placement of percutaneous nephroureteral stent for kidney/bladder drainage, the ultrathane cope nephroureterostomy set had air bubbles in the syringe as they drew back on it.As reported, the device was removed and another like device was used to complete the procedure successfully.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Additional information: d10-device available for eval: yes; product received on: 06/25/2018.Investigation evaluation: a review of the documentation and visual inspection/dimensional verification/functional test of the device was conducted during the investigation.The customer returned one 8.5 french mac-loc catheter in a used condition.Biomatter was present on the device.There did not appear to be any surface damage on the device.Discoloration was noted near the threads on the hub.The device was returned with the mac-loc in the unlocked position.A leak test was conducted by clamping the distal end of the catheter tubing with hemostats and injecting room temperature water into the proximal end.The leak test was able to confirm the presence of a leak between the catheter tubing and connector cap.Tug and twist tests were conducted revealing that the proximal assembly was secure.The connector cap was removed by dissociating the adhesive bond with ipa.Upon removing the cap, the suture string was found wound in the threads.The flare appeared lopsided, slightly shallow, with a diameter measuring at 0.250".Due to the compression of the flare within the cap and the potential damage upon removal, it cannot be determined whether the flare was manufactured to specifications.The connector cap inner diameter, mac-loc hub inner diameter, catheter tubing outer diameter, and number of threads showing between the hub and cap were measured and all found to be within manufacturing specifications.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest that the device was not manufactured to specification.The lot number of the device is not known; accordingly, a review of the device history record and complaint lot search could not be conducted.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.Appropriate measures have been initiated to address this failure mode.We have notified the appropriate personnel and 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 new event description information to report at this time.

• 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: 7501838
• MDR Text Key: 107825515
• Report Number: 1820334-2018-01386
• Device Sequence Number: 1
• Product Code: LJE
• 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: 08/24/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: ULT8.5-8.5-24-NUCL-B-RH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/10/2018
• Supplement Dates Manufacturer Received: 07/25/2018
• Supplement Dates FDA Received: 08/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1