MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 6MM10CM 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4400610S

Device Problems Indicator; Defective Component

Event Date 11/08/2019

Event Type  Malfunction  

• Brand Name: POWERFLEXPRO 6MM10CM 80
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes , FL 33014 ; 7863138372
• MDR Report Key: 9401228
• Report Number: 9616099-2019-03379
• Device Sequence Number: 1
• Product Code: LIT
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/03/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/03/2019
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 4400610S
• Device Catalogue Number: 4400610S
• Device LOT Number: 82155904
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/09/2019
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 06/26/2019
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial