BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABER

    MDR report key: 20030616 · Received August 22, 2024

    Report

    Report Number
    3007635982-2024-00208
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 24, 2024
    Report Date
    August 22, 2024
    Manufacturer
    CORDIS US. CORP
    Product Code
    LIT
    UDI-DI
    20705032069745
    PMA / PMN Number
    K971010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY: B5. THIS EVENT NO LONGER MEETS THE DEFINITION OF A MALFUNCTION THAT REQUIRES SUBMISSION OF A REGULATORY REPORT. NO ADDITIONAL REPORTS WILL BE FORTHCOMING. THIS CASE IS NO LONGER CONSIDERED REPORTABLE. MALFUNCTION CODE OF BALLOON-LEAKAGE NO LONGER APPLIES.

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS AVAILABLE FOR ANALYSIS, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 0

    AS REPORTED, THE 8MM10CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON LUER HUB LEAKED CONTRAST AGENT AS THE PRESSURE PUMP FILLED THE BALLOON TO DILATE THE LESION. THE BALLOON WAS INFLATED ONE TIME PRIOR TO THE LEAK. RESISTANCE/ FRICTION WAS NOTED WHILE INSERTING THE BALLOON CATHETER THROUGH THE ROTATING HEMOSTATIC VALVE AND WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS ALSO A DIFFICULTY NOTED WHILE CROSSING THE LEGION WITH THE BALLOON CATHETER. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE USE OF A NON-CORDIS BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE LESION WAS NOTED TO HAVE MODERATE CALCIFICATION. THE VESSEL WAS NOTED TO HAVE MODERATE TORTUOSITY. THE LESION HAD A 50% STENOSIS. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THE CATHETER WAS NEVER IN AN ACUTE BEND AND WAS NOT KINKED DURING USE. THE CONTRAST TO SALINE RATIO WAS 1:1. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    AS REPORTED, THE 8MM10CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON LEAKED CONTRAST AGENT AS THE PRESSURE PUMP FILLED THE BALLOON TO DILATE THE LESION. THE BALLOON WAS INFLATED ONE TIME PRIOR TO THE LEAK. RESISTANCE/ FRICTION WAS NOTED WHILE INSERTING THE BALLOON CATHETER THROUGH THE ROTATING HEMOSTATIC VALVE AND WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS ALSO A DIFFICULTY NOTED WHILE CROSSING THE LEGION WITH THE BALLOON CATHETER. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE USE OF A NON-CORDIS BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE LESION WAS NOTED TO HAVE MODERATE CALCIFICATION. THE VESSEL WAS NOTED TO HAVE MODERATE TORTUOSITY. THE LESION HAD A 50% STENOSIS. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THE CATHETER WAS NEVER IN AN ACUTE BEND AND WAS NOT KINKED DURING USE. THE CONTRAST TO SALINE RATIO WAS 1:1. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013254 SABER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT CORDIS US. CORP 82308127 20705032069745

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TERUMO V18 GUIDEWIRE| UNK CORDIS CATHETER