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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER RX6MM10CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER RX6MM10CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51006010L
Device Problems Shaft; Leak / Splash
Event Date 03/12/2020
Event Type  Malfunction  
Manufacturer Narrative

This is one of two products involved with the reported event. The medical device reporting reference number for these events are 9616099-2020-03636. Device history record (dhr) review was conducted and the product met quality requirements for product acceptance. This device was received for analysis, but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt.

 
Event Description

The 6mm 10cm 155 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter (bc) was inserted but the pressure was not able to make it rise during its initial inflation; it was removed from the patient body and leakage from its shaft was confirmed. It was replaced with a new 2mm 30cm 155 saber rx pta balloon catheter; however, the same issue occurred. Therefore, it was replaced with a new saber pta and the procedure was completed. There was no reported patient injury. A non-cordis guidewire crossed the lesion. The lesion was below-the-knee. A contralateral approach was made from the right superficial femoral artery. The devices are expected to be returned for analysis.

 
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Brand NameSABER RX6MM10CM155
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 Key9946650
Report Number9616099-2020-03637
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/06/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/09/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number51006010L
Device Catalogue Number51006010L
Device LOT Number82181109
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/30/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/14/2019
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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