BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABER PTA DILATATION CATHETER

    MDR report key: 4223074 · Received November 4, 2014

    Report

    Report Number
    9616099-2014-00717
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 9, 2014
    Report Date
    December 9, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    LIT
    PMA / PMN Number
    K971010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: GUIDING SHEATH (6FR/23CM PARENT, MEDIKIT), AND GUIDEWIRE (0.018INCH ASTATO, ASAHI INTECC). (B)(6). THIS DEVICE IS NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING PTA WITH A SABER BALLOON CATHETER, IT RUPTURED AT EIGHT ATMOSPHERES. IT WAS EXCHANGED FOR A NEW SABER BALLOON AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. PTA WAS BEING PERFORMED OF A TARGET LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE LESION WAS MODERATELY CALCIFIED AND NOT TORTUOUS. THE RATE OF STENOSIS WAS 100% (CHRONIC TOTAL OCCLUSION). AN APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY WITH A GUIDING SHEATH (NON-CORDIS). AFTER THE LESION WAS CROSSED WITH A GUIDEWIRE (NON-CORDIS), A SABER WAS DELIVERED TO AND INFLATED AT THE LESION. HOWEVER IT RUPTURED AT EIGHT ATMOSPHERES DURING ITS INITIAL-DILATION. THEREFORE IT WAS REMOVED FROM THE PATIENT AND EXCHANGED FOR ANOTHER NEW SABER (4/10MM). THE PROCEDURE FINISHED SUCCESSFULLY. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. THE BRAND OF CONTRAST MEDIA AND THE CONTRAST TO SALINE RATIO ARE UNKNOWN. THE INFLATION DEVICE WAS AN EVEREST AND IT 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 BALLOON INFLATED NORMALLY. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. IT WAS EASILY REMOVED FROM THE VESSEL AND FROM THE OTHER DEVICES. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF LOT 17015999 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED BALLOON BURST COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, VESSEL CHARACTERISTICS (CALCIFICATION, 100% STENOSIS) MAY HAVE CONTRIBUTED TO THE REPORTED BALLOON BURST. NEITHER THE DHR NOR THE INFORMATION AVAILABLE SUGGESTS THAT THE REPORTED BURST COULD BE RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. THE BRAND OF CONTRAST MEDIA AND THE CONTRAST TO SALINE RATIO ARE UNKNOWN. THE INFLATION DEVICE WAS AN EVEREST AND IT 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 BALLOON INFLATED NORMALLY. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. IT WAS EASILY REMOVED FROM THE VESSEL AND FROM THE OTHER DEVICES. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING PTA WITH A SABER BALLOON CATHETER, IT RUPTURED AT 8 ATM. IT WAS EXCHANGED FOR A NEW SABER BALLOON AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. PTA WAS BEING PERFORMED OF A TARGET LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE LESION WAS MODERATELY CALCIFIED AND NOT TORTUOUS. THE RATE OF STENOSIS WAS 100% (CTO). AN APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY WITH A GUIDING SHEATH (6FR/23CM PARENT, MEDIKIT). AFTER THE LESION WAS CROSSED WITH A GUIDEWIRE (0.018INCH ASTATO, ASAHI INTECC), A SABER WAS DELIVERED TO AND INFLATED AT THE LESION. HOWEVER, IT RUPTURED AT 8 ATM DURING ITS INITIAL-DILATION. THEREFORE IT WAS REMOVED FROM THE PATIENT AND EXCHANGED FOR ANOTHER NEW SABER (4/10MM). THE PROCEDURE FINISHED SUCCESSFULLY. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706173 SABER PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS CORPORATION 48004002S 17015999

    Patients

    Seq Age Sex Outcome Treatment
    1