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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER RX7MM4CM155 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER

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CORDIS CASHEL SABER RX7MM4CM155 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER Back to Search Results
Model Number N/A
Device Problem Unintended Movement (3026)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/24/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Concomitant medical products: guiding catheter (destination, terumoguidewire (cruise, asahi intecc). (b)(6). Please note that the device in this report is not sold in the us, however, it is similar to other cordis pta balloon catheters with the lit product code. The device was returned but the engineering report is pending. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
During use of a 7mm4cm155 saber rx percutaneous transluminal angioplasty (pta) balloon catheter, there was an abnormality felt with the marker which seemed to be far away and out of position. The doctor decided that it could not be used safely, and it will be returned for analysis. The balloon had been delivered and inflated as usual. The 75% occluded target lesion was the left external iliac artery with moderate vessel tortuosity. The access site was the inguinal region. The procedure being performed was a stent that was implanted in the left external iliac artery. The contrast media used was opaque injection, fuji pharma at a 1:1 contrast to saline ratio. An everest indeflator by medtronic was used in the procedure. The same indeflator was used successfully with other devices. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and no resistance/friction while inserting the balloon through the guide catheter. There was no difficulty advancing the balloon catheter through the vessel and no difficulty crossing the lesion. The catheter was never in an acute bend. The event occurred at the lesion. The balloon inflated normally was there was no difficulty removing it.
 
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Brand NameSABER RX7MM4CM155
Type of DevicePERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
Manufacturer (Section D)
CORDIS CASHEL
cahir road
co, tipperaru
cashel
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
co. tipperary
cashel
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key8708527
MDR Text Key197610437
Report Number9616099-2019-03025
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 07/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2021
Device Model NumberN/A
Device Catalogue Number51007004L
Device Lot Number82160722
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/13/2018
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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