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

Model Number N/A

Device Problem Obstruction of Flow (2423)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: guidewire.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 for a bilateral nephroureterostomy catheter exchange in the right and left renal tracts from the kidneys to bladder.Within two months of insertion, the patient "blocks his nephroureterstomies." this has occurred "multiple" times in the past.No other adverse effects were reported for this incident.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation: a customer at (b)(6) hospital (united kingdom) reported that ultrathane cope nephroureterostomy set device became blocked within two months of placement in a patient's renal tract.Each time the customer noted a blockage, the device was removed and replaced.There was no maintenance protocol for the devices in order to minimize the risk of infection.The patient did not experience any additional adverse effects.A review of the complaint history, instructions for use (ifu), manufacturing instructions, and quality control of the device were conducted during the investigation.The customer did not return the complaint devices for evaluation.This customer previously reported two additional complaints for two devices placed in the same patient which became blocked.They returned both devices to cook for evaluation.Both devices had encrusted biological matter blocking the sideports of the distal pigtail loop.Cook did not identify nonconformances on either device.Additionally, a document based investigation evaluation was performed.There are appropriate controls in place to detect this failure prior to distribution.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: "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 customer did not provide the lot number for this complaint.The sales records to this customer were reviewed and the complaint lot could not be identified.Therefore, the device history record (dhr) of the complaint devices could not be conducted.However, the customer reported the same failure on two known ultrathane cope nephroureterostomy set lots (reported under medwatch report #: 1820334-2019-03026 and #:1820334-2019-03029).These devices were used in the same patient as in this report.The device history records for these lots were reviewed and no evidence of nonconforming material in house or in the field was found.The customer reported that the devices became "blocked" within two months of placement, necessitating a stent exchange.The doctor indicated that they believe the patient's diet has likely caused the stent to become blocked more quickly than in the past.Based on information from the customer, and evaluation of similar devices placed in the same patient, a possible cause for this failure is the patient's physiology/diet.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.

• 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: 9489270
• MDR Text Key: 182724294
• Report Number: 1820334-2019-03139
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

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 Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 03/26/2020
• Supplement Dates FDA Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention