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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER RX6MM25CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER RX6MM25CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51006025L
Device Problems Indicator; Structural Problem; Catheter
Event Date 07/27/2018
Event Type  Malfunction  
Manufacturer Narrative

Additional information to include facility name: (b)(6) general hospital. The product was not returned for analysis. Device history record (dhr) review was conducted and the product met quality requirements for product acceptance. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

During a in-stent re-stenosis, it was reported that the saber balloon catheter got lengthen 1cm or 2cm from the balloon marker when an attempt was made to inflate. There was no patient injury. The lesion was the superficial femoral artery. No other information was provided.

 
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Brand NameSABER RX6MM25CM155
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, tipperary 0000
EI  0000
Manufacturer (Section G)
CORDIS CASHEL
cashel, tipperary
cashel, tipperary 0000
EI  0000
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes , FL 33014
7863138372
MDR Report Key7813275
Report Number9616099-2018-02341
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/10/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/24/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2020
Device MODEL Number51006025L
Device Catalogue Number51006025L
Device LOT Number17677325
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/01/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/26/2017
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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