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

Model Number N/A

Device Problem Difficult to Remove (1528)

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

Event Date 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

The 510k status: 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

The customer reported that, while in use in a patient, the ultrathane cope nephroureterostomy stent could not be separated from the blue stiffener included in the set.The product was removed form the patient, and a new one was opened and utilized to complete the procedure successfully, with no adverse events or additional procedures reported.The device has been returned for evaluation; however, as of the date of this report, the investigation is still pending.

Manufacturer Narrative

Investigation ¿ evaluation.A review of the complaint history , device history record, drawings, instructions for use (ifu), specifications, quality control data, dimensional verification, and functional testing of the returned device was conducted during the investigation.One used device was returned.The stiffener was lodged in the catheter and could only be removed with a significant amount of force.The catheter inner diameter and stiffener outer diameter both measured within specification.A document-based investigation evaluation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the provided information, examination of the returned device, and the results of the investigation; a definitive root cause could not be determined.Per the risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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: 7216939
• MDR Text Key: 98283788
• Report Number: 1820334-2018-00051
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00827002481640
• UDI-Public: (01)00827002481640(17)200331(10)7794606
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/19/2018

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 Model Number: N/A
• Device Catalogue Number: ULT10.2-10.2-24-NUCL-B-RH
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/02/2018
• Initial Date FDA Received: 01/24/2018
• Supplement Dates Manufacturer Received: 01/30/2018
• Supplement Dates FDA Received: 02/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1