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

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Unspecified Infection (1930); Foreign Body In Patient (2687); No Code Available (3191)

Event Date 05/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The customer reported that a patient underwent percutaneous placement of a ultrathane cope nephroureterostomy stent on (b)(6) 2016.The stent was explanted approximately two weeks later.The patient reportedly developed an infection approximately 7 months following device explant in (b)(6) 2016.The patient underwent ureteroscopic evaluation; which identified a retained portion of the device tether that was infected and calcified.The retained tether was explanted and the patient treated for infection.No further device event or patient information is available.The device is not available for evaluation.

Manufacturer Narrative

Investigation-evaluation: a review of documentation, manufacturing instructions, instructions for use (ifu), complaint history, deice history record, specifications and quality control data was conducted during the investigation.The device was not returned and no pictures were taken.The device history record was reviewed and four non-conformances from the same lot were noted, however these were unrelated to the reported mode of failure and scrapped prior to packaging.A review of complaint history revealed that this complaint is the only reported complaint associated to the complaint lot number.Cook medical has several risk controls in place for the reported suture line.Each lot is provided with a certificate of performance and quality control upon purchase as a raw material by cook.These sutures are then inspected at multiple points along the manufacturing and packaging stages of the complete device's lifecycle.Based on the provided information, no product returned, and the investigation, a definitive root cause cannot be established or reported at this time.Per the quality engineering risk assessment no further action is required.We have notified the appropriate personnel and will continue to monitor 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6563366
• MDR Text Key: 75035677
• Report Number: 1820334-2017-00965
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00827002481763
• UDI-Public: (01)00827002481763(17)181110(10)6369777
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-24-NUCL-B-RH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/13/2017
• Initial Date FDA Received: 05/12/2017
• Supplement Dates Manufacturer Received: 10/03/2017
• Supplement Dates FDA Received: 10/17/2017
• Date Device Manufactured: 11/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention