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

Catalog Number ULT8.5-8.5-26-NUCL-B-RH

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: not exempt; pma/510(k) #: pre-amendment.(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

As reported, an ultrathane cope nephroureterectomy catheter was placed into the bladder of a patient during a nephroureteral stent placement procedure.It was noted during the procedure that the stylet became lodged in the distal pigtail of the catheter.When the physician attempted to remove the stylet, the catheter would accordion and pull the distal portion back up from the bladder.A wire guide was used in an attempt to remove the stylet, but was unsuccessful.The physician slit the catheter, placed another wire guide alongside stylet and removed the whole system.The catheter was totally removed and successfully replaced with a like device.

Manufacturer Narrative

Investigation/evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, as well as a functional test, visual inspection and dimensional verification of the returned device was conducted during the investigation.One unlocked 8.5fr mac-loc catheter was returned for evaluation in used and damaged condition with a portion of the flexible stiffener included.The device was returned in three pieces.The first piece was comprised of the mac-loc hub, connector cap and approximately 4.2cm of catheter tubing.The second piece consisted of approximately 5.9cm of catheter tubing beginning and ending with a separation.The third piece was comprised of approximately 47.6cm of catheter tubing beginning with a separation and ending with the distal pigtail curl.The returned portion of the flexible stiffener was approximately 64.6cm long and missing its proximal hub.Biomatter was present on the device and the separations appeared to be cuts.Surface damage was noted on the first piece, while one of the ends on the second piece appeared nearly separated.There was a cut on the third piece approximately 0.8cm in length running from the cut to the pigtail curl.On the same piece, approximately 7cm from the pigtail was a 2.2cm opening in the wall of the catheter.The opening appeared man made and was likely created to pull the flexible stiffener out of the catheter.On one end of the plastic stiffener there were numerous kinks, implying difficulty.A portion of the stiffener was also thin and elongated, likely from attempting to pull the stiffener out.Dimensional analysis confirmed that the device and components were manufactured to the correct specifications and tolerances.The flexible stiffener was unable to be measured due to device damage.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest issues or gaps that could contribute to the release of nonconforming product related to the reported failure mode.The instructions for use instruct the user to inspect the device prior to use to ensure that no damage has occurred.A review of the device history record revealed one nonconformance in a catheter tubing subassembly lot for blockage, but the affected device was scrapped.There was an additional nonconformance found in a similar device lot for an incorrect flexible stiffener size, but the affected device was also scrapped.It should be noted that there were no other complaints reported in this lot number.Based on the information provided, the examination of the returned product and the results of our investigation, a possible cause could be traced to the user.It is possible that the customer did not use the stiffener and catheter together appropriately, causing the flexible stiffener to become lodged.Biological matter clogging within the catheter could also make it difficult to remove the stiffener.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We 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 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: 7819145
• MDR Text Key: 118402436
• Report Number: 1820334-2018-02494
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00827002481800
• UDI-Public: (01)00827002481800(17)210308(10)8654149
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

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 Expiration Date: 03/08/2021
• Device Catalogue Number: ULT8.5-8.5-26-NUCL-B-RH
• Device Lot Number: 8654149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 08/27/2018
• Supplement Dates Manufacturer Received: 10/31/2018
• Supplement Dates FDA Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1