BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2CM PERIPHERAL CUTTING BALLOON

    MDR report key: 9414141 · Received December 4, 2019

    Report

    Report Number
    2134265-2019-14985
    Event Type
    Malfunction
    Date Received
    December 4, 2019
    Date of Event
    November 20, 2019
    Report Date
    February 6, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    PMA / PMN Number
    K070951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    G5: PREMARKET UPDATED TO K070951. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. THE FOLLOWING ATTRIBUTES WERE CONSIDERED DURING ANALYSIS: A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON WAS NOT FOLDED WHICH INDICATES THAT THE BALLOON WAS SUBJECTED TO POSITIVE PRESSURE. BLOOD WAS IDENTIFIED WITHIN THE BALLOON AND INFLATION LUMEN WHICH IS EVIDENCE OF A DEVICE LEAK. THE RETURNED DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT. POSITIVE PRESSURE WAS APPLIED WHEN LIQUID WAS OBSERVED TO BE LEAKING FROM A BALLOON PINHOLE LOCATED APPROXIMATELY 9MM PROXIMAL OF THE DISTAL MARKERBAND. AN EXAMINATION OF THE BALLOON MATERIAL AND MARKERBANDS IDENTIFIED NO ISSUES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THIS COMPLAINT. THE RATED BURST PRESSURE FOR THIS DEVICE IS 10 ATMOSPHERES. A VISUAL AND MICROSCOPIC EXAMINATION OBSERVED NO DAMAGE TO THE TIP OR BLADES. ALL BLADES WERE PRESENT AND FULLY BONDED TO THE BALLOON SURFACE. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO KINKS OR DAMAGE TO THE SHAFT OF THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS CEPHALIC VEIN. A 5.00MM/2.0CM/50CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED UPON THIRD INFLATION AT SEVERAL ATM AND WAS REMOVED WITHOUT PROBLEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS SIMPLY PULLED OUT FROM THE PATIENT'S BODY. THE PATIENT CONDITION WAS STABLE POST PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS CEPHALIC VEIN. A 5.00MM/2.0CM/50CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED UPON THIRD INFLATION AT SEVERAL ATM AND WAS REMOVED WITHOUT PROBLEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS SIMPLY PULLED OUT FROM THE PATIENT'S BODY. THE PATIENT CONDITION WAS STABLE POST PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS CEPHALIC VEIN. A 5.00MM/2.0CM/50CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED UPON THIRD INFLATION AT SEVERAL ATM AND WAS REMOVED WITHOUT PROBLEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204989 2CM PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA LIT BOSTON SCIENTIFIC CORPORATION 24628 0023662395

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE - FUGA| GUIDEWIRE - FUGA| GUIDEWIRE - FUGA| INFLATION DEVICE - KANEKA| INFLATION DEVICE - KANEKA| INFLATION DEVICE - KANEKA