BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2CM PERIPHERAL CUTTING BALLOON?

    MDR report key: 3923584 · Received July 9, 2014

    Report

    Report Number
    2134265-2014-04017
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K070951
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: INVESTIGATION COMPLETED. THE DEVICE WAS RETURNED FOR EVALUATION. DEVICE ANALYSIS NOTED 1 BLADE AND PAD HAD DETACHED FROM THE BALLOON. THE 3 REMAINING BLADES WERE FULLY BONDED TO THE BALLOON. NO DAMAGE WAS NOTED TO THE BLADES. THE RETURNED DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT. POSITIVE PRESSURE WAS APPLIED WHEN A LEAK WAS NOTED. A FURTHER MICROSCOPIC ANALYSIS CONFIRMED A LONGITUDINAL BALLOON TEAR IN THE PROXIMAL BALLOON BODY. THE LONGITUDINAL TEAR WAS LOCATED ON THE OPPOSITE SIDE OF THE BLADE AND PAD DETACH SITE. THE BALLOON MATERIAL ALSO EXHIBITED CREASING AT THE LOCATION OF THE DETACHED BLADE AND PAD. NO DAMAGE WAS NOTED TO THE CATHETER SHAFT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT THE TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VESSEL RUPTURE AND BLADE DETACHMENT OCCURRED. A 90% STENOSED 4CM TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT BRACHIAL VEIN. A 6.00MM / 2.0CM / 50CM OTW PERIPHERAL CUTTING BALLOON¿ WAS USED IN A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING PROCEDURE, A NON BSC INTRODUCER SHEATH WAS INSERTED THROUGH ANTEGRADE APPROACH. A NON BSC GUIDE WIRE WAS ADVANCED TO THE LESION AND THE BALLOON WAS INFLATED WITH A DOG BONE SHAPE SINCE THE LESION WAS TIGHT. IT WAS FURTHER OBSERVED THAT IT TOOK MORE THAN 5 SECONDS FOR EACH BALLOON WHILE RAISING THE PRESSURE AS DILATATION WAS PERFORMED. HOWEVER, IT WAS OBSERVED ON THE 3RD INFLATION IN 60 SECONDS THAT THE BALLOON RUPTURED AT 10 ATM. FURTHERMORE, THE VESSEL WAS RUPTURED. IN ADDITION, THE PHYSICIAN OBSERVED THAT THE VESSEL WAS FRAGILE AND COULD NOT WITHSTAND THE PRESSURE FROM BALLOON INFLATION. ASTRICTION WAS IMMEDIATELY PERFORMED AND THE BLEEDING WAS STOPPED. THE DEVICE WAS CHECKED AND CONFIRMED THAT ONLY THREE BLADES WERE PRESENT. IT WAS SUSPECTED THAT ONE BLADE DETACHED INSIDE THE PATIENT AND WAS CONFIRMED UNDER FLUOROSCOPIC GUIDANCE THAT A BLADE LIKE COMPONENT WAS AT COLLATERAL NEAR THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. GOOD BLOOD FLOW WAS CONFIRMED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VESSEL RUPTURE AND BLADE DETACHMENT OCCURRED. A 90% STENOSED 4CM TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT BRACHIAL VEIN. A 6.00MM / 2.0CM / 50CM OTW PERIPHERAL CUTTING BALLOON¿ WAS USED IN A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING PROCEDURE, A NON BSC INTRODUCER SHEATH WAS INSERTED THROUGH ANTEGRADE APPROACH. A NON BSC GUIDE WIRE WAS ADVANCED TO THE LESION AND THE BALLOON WAS INFLATED WITH A DOG BONE SHAPE SINCE THE LESION WAS TIGHT. IT WAS FURTHER OBSERVED THAT IT TOOK MORE THAN 5 SECONDS FOR EACH BALLOON WHILE RAISING THE PRESSURE AS DILATATION WAS PERFORMED. HOWEVER, IT WAS OBSERVED ON THE 3RD INFLATION IN 60 SECONDS THAT THE BALLOON RUPTURED AT 10 ATM. FURTHERMORE, THE VESSEL WAS RUPTURED. IN ADDITION, THE PHYSICIAN OBSERVED THAT THE VESSEL WAS FRAGILE AND COULD NOT WITHSTAND THE PRESSURE FROM BALLOON INFLATION. ASTRICTION WAS IMMEDIATELY PERFORMED AND THE BLEEDING WAS STOPPED. THE DEVICE WAS CHECKED AND CONFIRMED THAT ONLY THREE BLADES WERE PRESENT. IT WAS SUSPECTED THAT ONE BLADE DETACHED INSIDE THE PATIENT AND WAS CONFIRMED UNDER FLUOROSCOPIC GUIDANCE THAT A BLADE LIKE COMPONENT WAS AT COLLATERAL NEAR THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. GOOD BLOOD FLOW WAS CONFIRMED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400382 2CM PERIPHERAL CUTTING BALLOON? CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA LIT BOSTON SCIENTIFIC - GALWAY M001BP50620B0 16745532

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INFLATION DEVICE:KANEKA| GUIDEWIRE:RADIFOCUS| INTRODUCER SHEATH:MOSQUITO 7F