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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER RX4MM15CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER RX4MM15CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51004015L
Device Problem Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/27/2019
Event Type  malfunction  
Manufacturer Narrative
The product was not returned for analysis. Device history record (dhr) review was conducted and the product met quality requirements for product acceptance. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported the 4mm 15cm 155 saber percutaneous transluminal angioplasty (pta) balloon catheter was used for post dilation. However, it ruptured at six (6) atmospheres (atm). There was no reported patient injury. Therefore, it was replaced with a high pressure balloon and another saber (5mm). There was no issue when the saber pta was prepped. The lesion was the superficial femoral artery. The doctor commented that the issue might have occurred due to severe calcification. The device will not be returned for evaluation because it was discarded due to infectious disease.
 
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Brand NameSABER RX4MM15CM155
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 Key9492689
MDR Text Key195037756
Report Number9616099-2019-03415
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
Type of Report Initial,Followup
Report Date 01/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Model Number51004015L
Device Catalogue Number51004015L
Device Lot Number17717481
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/25/2017
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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