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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL AVIATOR PLUS .014 4.5X20 142CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL AVIATOR PLUS .014 4.5X20 142CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 4244520W
Device Problem Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2019
Event Type  Malfunction  
Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17766962 presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported, during a carotid artery stenting (cas) procedure, a. 014 4. 5x20 142cm aviator plus percutaneous transluminal angioplasty (pta) balloon catheter used for post dilation of a non-cordis stent, ruptured at approximately three atmospheres (3 atm). The rupture was confirmed by contrast media on angiography. The device was therefore removed from the patient¿s body and was replaced with a new same sized non-cordis balloon catheter to complete the procedure. There was no reported patient injury. The device will not be returned as it was discarded in the hospital.

 
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Brand NameAVIATOR PLUS .014 4.5X20 142CM
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key9440608
MDR Text Key199106554
Report Number9616099-2019-03393
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK071189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/15/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/09/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2021
Device Catalogue Number4244520W
Device LOT Number17766962
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/02/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/23/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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