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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX6MM10CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER RX6MM10CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51006010L
Device Problem Burst Container or Vessel (1074)
Patient Problem Stenosis (2263)
Event Date 07/27/2021
Event Type  malfunction  
Manufacturer Narrative
This device is not available for testing and evaluation. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, the 6mm 10cm 155 saber rx percutaneous transluminal angioplasty (pta) balloon catheter was inserted and inflated but it ruptured at 8 atmospheres (atm) during its initial inflation. Therefore, the device was replaced with another non-cordis balloon catheter and it inflated successfully. The procedure was completed with a non-cordis drug-coated balloon catheter. There was no reported patient injury. The lesion was 90 % stenosis of the superficial femoral artery. A contralateral approach was made. A 6f non-cordis sheath was used. An unknown 0. 014 guidewire crossed the lesion. The device will not be returned for analysis because it was discarded at the hospital.
 
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Brand NameSABER RX6MM10CM155
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60 avenue
miami lakes, FL 33014
7863138372
MDR Report Key12345197
MDR Text Key268706406
Report Number9616099-2021-04798
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 08/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number51006010L
Device Catalogue Number51006010L
Device Lot Number82191520
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 Received08/22/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/26/2020
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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