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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS DE MEXICO SABER RX2MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS DE MEXICO SABER RX2MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51002004L
Device Problems Balloon (419); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/06/2019
Event Type  Malfunction  
Manufacturer Narrative

Telephone number is: (b)(6). This device is available for analysis but has not yet been received. A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan. Additional information is pending and will be submitted within 30 days upon receipt. Please note that the saber device in this report is not sold in the u. S, but it is similar to other cordis pta balloon catheters with the lit product code that are sold in the u. S.

 
Event Description

During a pre - plain old balloon angioplasty (poba) procedure, the balloon of the 2mm x 4cm x 155cm saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter crossed the lesion however it ruptured within its nominal pressure. Therefore, the device was removed from the patient's body and the procedure was completed with a non-cordis balloon catheter. There was no reported patient injury. The target lesion was the superficial femoral artery (sfa) and had calcification. The device was prepped without any issue. The device is expected to be returned for evaluation.

 
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Brand NameSABER RX2MM4CM155
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS DE MEXICO
circuito int nte 1820
juarez 32575
MX 32575
Manufacturer (Section G)
CORDIS DE MEXICO
circuito int nte 1820
juarez 32575
MX 32575
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key9535447
MDR Text Key200249816
Report Number9616099-2019-03445
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,Followup
Report Date 02/11/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/31/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2020
Device MODEL Number51002004L
Device Catalogue Number51002004L
Device LOT Number17661083
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 Received02/06/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/04/2017
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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