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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER 2.5MM20CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER 2.5MM20CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48002520X
Device Problem Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/26/2019
Event Type  Malfunction  
Manufacturer Narrative

This device is available for analysis but has not yet been received. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported, the 2. 5mm x 20cm x 150 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter ruptured on 14 atmosphere (atm) pressure. The device was used in expanding the lower knee lesion. There was no reported patient injury. The device is expected to be returned for evaluation.

 
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Brand NameSABER 2.5MM20CM 150
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, tipperary 0000
EI 0000
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, tipperary 0000
EI 0000
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key9481251
MDR Text Key199107844
Report Number9616099-2019-03406
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK971010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/27/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/17/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number48002520X
Device Catalogue Number48002520X
Device LOT Number82168345
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/29/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/06/2019
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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