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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER RX4MM30CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER RX4MM30CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 51004030L
Device Problems Indicator; Structural Problem; Catheter
Event Date 05/29/2019
Event Type  Malfunction  
Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported, a plain old balloon angioplasty (poba) was performed with a saber rx pta balloon catheter (4mm30cm155) ), the saber rx pta balloon was inflated within its nominal pressure. However, the balloon got lengthened from about 1. 5 to 2-centimeters (cm) from the proximal maker and it was inflated. There was no reported patient injury. Yet, the doctor wondered how long the acceptable length is. The lesion was the superficial femoral artery. Initially, this was a percutaneous transluminal angioplasty (pta) case. A contralateral approach was made with a non-cordis guiding catheter and a non-cordis guide wire crossed the lesion. The contrast to saline ration was 1:1: the device will be returned for analysis.

 
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Brand NameSABER RX4MM30CM155
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 Key8743846
Report Number9616099-2019-03042
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 07/31/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/28/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number51004030L
Device LOT Number82159348
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/03/2018
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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