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

Catalog Number	FOR418-18-135-6-20
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2015
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• MDR Report Key: 8178837
• Report Number: 1820334-2018-03857
• Device Sequence Number: 1987745
• Product Code: NIN
• UDI-Device Identifier: 10827002566276
• UDI-Public: (01)10827002566276(17)170101(10)4730213
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/19/2018

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR