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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER RX7MM4CM155 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER

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CORDIS CASHEL SABER RX7MM4CM155 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER Back to Search Results
Model Number N/A
Device Problems Indicator; Unintended Movement; Catheter
Event Date 05/24/2019
Event Type  Malfunction  
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Brand NameSABER RX7MM4CM155
Type of DevicePERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
Manufacturer (Section D)
CORDIS CASHEL
cahir road
co, tipperaru
cashel
EI 
Manufacturer (Section G)
CORDIS CASHEL
cahir road
co. tipperary
cashel
EI 
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes , FL 33014
7863138372
MDR Report Key8708527
Report Number9616099-2019-03025
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 07/31/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/18/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number51007004L
Device LOT Number82160722
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/11/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/13/2018
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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