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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 06/09/2018

Event Type  Injury  

Manufacturer Narrative

Device available for evaluation: unknown.Occupation: charge tech.Pma/510(k) #: pre-amendment.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 an ultrathane cope nephroureterectomy stent was placed in a patient during the "summer" of 2018.An unspecified amount of time after placement, the catheter was found to be leaking at the connection between the catheter and the hub.It is unknown if the catheter was replaced.Additional information regarding the event, patient demographics, and patient outcome has been requested but is currently unavailable.

Manufacturer Narrative

It was reported an ultrathane cope nephroureterostomy stent was placed in the patient's kidney for urine drainage.Nine days later, the drain was exchanged due to leakage at the hub.This event is recorded under this medwatch report #1820334-2018-03338.The next day, the replacement drain was found to be leaking and was exchanged again for a new drain of the same type.This event is recorded under this medwatch report (1820334-2018-03340).As reported, the patient did not experience any other adverse effects due to this occurrence.Patient code: 3191 [no code available]- additional procedure required to replace device 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.

Event Description

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

Manufacturer Narrative

D10 - device available for evaluation: no.Investigation ¿ evaluation.A review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a review of devices returned from the same lot, was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows one nonconforming event which could contribute to this failure mode; however, all of the returned devices for this lot were measured within specifications, so there is no evidence of non-conforming devices in the field.It should be noted there were three other reported complaints for this lot number.Based on the information provided, the examination of related returned product, and the results of our investigation, a definitive root cause could not be established.Measures are being conducted to address this failure mode.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.

• 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: 8052535
• MDR Text Key: 128250187
• Report Number: 1820334-2018-03340
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00827002481664
• UDI-Public: (01)00827002481664(17)210129(10)8544564
• 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: 02/08/2019

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: 01/29/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-10.2-26-NUCL-B-RH
• Device Lot Number: 8544564
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2018
• Initial Date FDA Received: 11/08/2018
• Supplement Dates Manufacturer Received: 11/14/2018; 01/18/2019
• Supplement Dates FDA Received: 12/06/2018; 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR