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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL POWERFLEX P3 F5 4X4 40 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL POWERFLEX P3 F5 4X4 40 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4204040T
Device Problems Balloon; Burst Container or Vessel ; Difficult to Insert; Catheter
Event Date 01/24/2018
Event Type  Malfunction  
Manufacturer Narrative

Device history record (dhr) review was conducted and the product met quality requirements for product acceptance. This device was received for analysis but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt.

 
Event Description

During a fistulagram in the thigh, it was reported that the power flex p3 balloon catheter (bc) would not inflate because the balloon was breaking as it got caught on part of the catheter graft. There was no patient injury. The patient had a herograft and there was a narrowing were they connected. There was an attempt to balloon the narrowing and the balloon would inflate for a short time and then break. The physician believes that the materials of the graft was shredding the balloons. Only one will be returned for analysis.

 
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Brand NamePOWERFLEX P3 F5 4X4 40
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, tipperary
EI 
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, tipperary
EI 
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes , FL 33014
MDR Report Key7290529
Report Number9616099-2018-01921
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/18/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/22/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date03/31/2019
Device MODEL Number4204040T
Device Catalogue Number4204040T
Device LOT Number17477977
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/07/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date01/25/2018
Event Location No Information
Date Manufacturer Received04/17/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/29/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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