MAUDE Adverse Event Report: COOK INC FORMULA 418 RENAL BALLOON-EXPANDABLE STENT

Catalog Number FOR418-18-135-6-20

Device Problem Device Slipped (1584)

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

Event Date 02/08/2015

Event Type  malfunction  

Manufacturer Narrative

The field for common name and product code was not populated due to a technical limitation.Common name: stent, renal and product code: nin.This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.

Event Description

It was reported that the when the formula 418 renal balloon-expandable stent was being prepared for use in an angiography of the right leg, it slipped off the balloon while being loaded onto the wire.It did not make patient contact and it is unknown how the procedure was completed, but there were no injuries or additional procedures reported.

• Brand Name: FORMULA 418 RENAL BALLOON-EXPANDABLE STENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 8178837
• MDR Text Key: 131324335
• Report Number: 1820334-2018-03857
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 10827002566276
• UDI-Public: (01)10827002566276(17)170101(10)4730213
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2017
• Device Catalogue Number: FOR418-18-135-6-20
• Device Lot Number: 4730213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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 Age: 65 YR