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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS MEXICO SABER RX5MM2CM155 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETE

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CORDIS MEXICO SABER RX5MM2CM155 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETE Back to Search Results
Model Number N/A
Device Problems Decrease in Pressure (1490); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/30/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was not returned for analysis. 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 device in the report is not sold in the u. S. , but it is similar to other us pta balloon catheters with the lit product code.
 
Event Description
As reported, the 5mm x 2cm x 155cm saber rapid-exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter (bc) was delivered to the lesion but it ruptured within its nominal pressure. There was no reported patient injury. The device will not be returned for analysis since it was discarded.
 
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Brand NameSABER RX5MM2CM155
Type of DevicePERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETE
Manufacturer (Section D)
CORDIS MEXICO
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 Key9364891
MDR Text Key198971625
Report Number9616099-2019-03368
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 12/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Model NumberN/A
Device Catalogue Number51005002L
Device Lot Number17681306
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 Received11/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/08/2017
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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