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

Catalog Number FOR418-18-80-6-20

Device Problems Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Common name: stent, renal and d2b.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 formula 418 renal balloon-expandable stent would not would not cross the lesion, and when it was removed, it was found to be stuck on the outer sheath, making it unusable.The procedure was completed with a new stent, and 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: 8178751
• MDR Text Key: 131310650
• Report Number: 1820334-2018-03851
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 10827002566146
• UDI-Public: (01)10827002566146(17)190112(10)6513012
• 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: Other Health Care Professional
• 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: 01/12/2019
• Device Catalogue Number: FOR418-18-80-6-20
• Device Lot Number: 6513012
• Was Device Available for Evaluation?: No
• 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: 01/12/2016
• 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