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 Complete Blockage (1094)

Patient Problem No Code Available (3191)

Event Date 01/29/2020

Event Type  Injury  

Manufacturer Narrative

Occupation: radiology.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 an ultrathane cope nephroureterostomy set placed for a bilateral nephroureterectomy catheter exchange on (b)(6) 2019.On (b)(6) 2020, the operator reported that the stent was "blocking" and was removed from the patient.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Event Description

Additional information was received on 17feb2020 indicating the left nephroureterostomy was placed in the left renal collecting system.The blockage occurred "between the kidney and the outside".Device was then flushed and unblocked.When attempting to advance the guidewire, it would not advance through the tip of the device.The device was replaced with another similar device to complete the procedure.

Manufacturer Narrative

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

Blank fields on this form indicate the information is unchanged, unknown or unavailable.D10 product received on: 24feb2020.Investigation evaluation.As reported, a 79-year-old male patient required placement of an ultrathane cope nephroureterostomy set for a left sided nephroureterectomy catheter exchange.Approximately two months after placement, the operator reported that the stent was "blocking¿ between the kidney and outside.The operator attempted to remove blockage utilizing saline flushes, and a guidewire was passed, but would not pass through the tip.Eventually the operator elected to replace the device with another similar device.No other adverse events were reported.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, as well as a visual inspection were conducted during the investigation.One used 8.5fr ult with biomatter was returned.The mac-loc was returned with the lever open.A white crusty substance was noticed on the distal pigtail.The catheter was flushed with water, the water was able to flush through without difficulty.The suture was missing from the mac-loc.The catheter was not visibly damaged.Additionally, a document-based investigation evaluation was performed.Appropriate controls are in place to detect this failure prior to distribution.The instructions for use (ifu) packaged with this device contains the following information: "this product is intended for use by physicians trained and experienced in placement of nephroureterostomy stents.Standard techniques should be employed." there are no known contraindications for placement listed in the ifu.The device history record (dhr) was reviewed.The final lot revealed four non-conformances.The catheter sub assembly lots revealed two non-conformances.There are two applicable non-conformances for "sideports, cluttered/rough/out of round" and "sideport, incorrect location or size or pattern or quantity or angle." the two nonconforming devices were scrapped.The sideports are 100% inspected to ensure that they are cleanly cut.There are adequate inspection activities to capture non-conformances prior to distribution.A complaint database search was completed on the lot and no additional complaints were found.There is no evidence the complaint device was manufactured out of specification or that non-conforming material from this lot in house or in the field.Additional information regarding the maintenance protocol and items injected through the catheter was received from the customer.Currently they do not have specific protocols in place for maintenance of these catheters.Based on the information provided, inspection of returned product, and results of the investigation, it was concluded that a maintenance issue and patient condition contributed to this incident.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook 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 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: 9707085
• MDR Text Key: 190558455
• Report Number: 1820334-2020-00345
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00827002481800
• UDI-Public: (01)00827002481800(17)220412(10)9664110
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2020

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: 04/12/2022
• Device Catalogue Number: ULT8.5-8.5-26-NUCL-B-RH
• Device Lot Number: 9664110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 02/13/2020
• Supplement Dates Manufacturer Received: 02/17/2020; 04/23/2020
• Supplement Dates FDA Received: 03/10/2020; 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TERUMO WIRE BENTSON WIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR