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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER RX2MM30CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER RX2MM30CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51002030L
Device Problems Balloon (419); Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/03/2019
Event Type  Malfunction  
Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82164644 presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported, a 2mm x 30cm 155cm saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter (bc) was delivered to the lesion and inflated, however, it ruptured within its nominal pressure. Therefore, it was replaced with another non-cordis balloon catheter and the procedure was completed. There was no reported patient injury. This was an endovascular therapy (evt) case. The target lesion was the superficial femoral artery (sfa) which had severe calcification. The device will not be returned for analysis due to infectious disease.

 
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Brand NameSABER RX2MM30CM155
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 Key9532228
MDR Text Key200250153
Report Number9616099-2019-03441
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/17/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/30/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number51002030L
Device Catalogue Number51002030L
Device LOT Number82164644
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/30/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/22/2019
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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