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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL AVIATOR PLUS .014 5.5X20 142CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL AVIATOR PLUS .014 5.5X20 142CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4245520W
Device Problems Material Frayed; Torn Material; Catheter; Tip
Event Date 12/04/2017
Event Type  Malfunction  
Manufacturer Narrative

A device history record (dhr) review of lot 17458065 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported, an aviator plus (. 014 5. 5x20 142cm) was inserted, but could not cross the lesion and the distal end got frayed. A chevalier tapered 30 could not cross the lesion and the distal end was damaged. Therefore, both devices were replaced with new devices to complete the procedure. No anomalies were confirmed during preparation. The procedure was completed successfully. There was no reported patient injury. The products were clinically used and will not be returned for analysis. The patient¿s information was unknown. The target lesion was unknown. The patient¿s vessel level of tortuousness and calcification was unknown. The rate of stenosis was unknown.

 
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Brand NameAVIATOR PLUS .014 5.5X20 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
MDR Report Key7154450
Report Number9616099-2017-01743
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 02/02/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/29/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2019
Device MODEL Number4245520W
Device Catalogue Number4245520W
Device LOT Number17458065
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 Received01/15/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2016
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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