BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING¿

    MDR report key: 2231144 · Received September 1, 2011

    Report

    Report Number
    2134265-2011-03743
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: RECEIVED PRODUCT CONSISTED OF A STERLING BALLOON CATHETER WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. WHEN POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER, WATER EMITTED FROM A LONGITUDINAL TEAR ON THE PROXIMAL END OF THE BALLOON. INSPECTION OF THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. IT WAS REPORTED THAT THE TARGET VESSEL WAS A CORONARY ARTERY/VESSEL WHEREAS THE STERLING PRODUCT FAMILY IS ONLY INDICATED FOR USE IN PERIPHERAL ARTERIES/VESSELS. STERLING DFU INDICATIONS FOR USE "THE STERLING OTW PTA BALLOON DILATATION CATHETER IS INDICATED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN THE PERIPHERAL VASCULATURE, INCLUDING ILIAC, FEMORAL, ILIO-FEMORAL, POPLITEAL AND RENAL ARTERIES, AND FOR THE TREATMENT OF OBSTRUCTIVE LESIONS OF NATIVE OR SYTHETIC ARTERIOVENOUS DIALYSIS FISTULAE. THIS DEVICE IS ALSO INDICATED FOR POST-DILATATION OF BALLOON EXPANDABLE AND SELF EXPANDING STENTS IN THE PERIPHERAL VASCULATURE." THE ROOT CAUSE CLASSIFICATION 'USER RELATED' WAS ASSIGNED. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: UNDER 18 YEARS OF AGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PULMONARY VALVE TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 80% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS PULMONARY ARTERY. THEY USED A 10.0 X 40/80 (5F) STERLING BALLOON AND A 7MM STERLING BALLOON AS DOUBLE BALLOONS. THE 10.0 X 40/80 (5F) STERLING BALLOON WAS INFLATED TWICE TO 5 ATMS. THE BALLOON RUPTURED AT 6 ATMS ON THE THIRD INFLATION. THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PULMONARY VALVE TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 80% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS PULMONARY ARTERY. THEY USED A 10.0 X 40/80 (5F) STERLING BALLOON AND A 7MM STERLING BALLOON AS DOUBLE BALLOONS. THE 10.0 X 40/80 (5F) STERLING BALLOON WAS INFLATED TWICE TO 5 ATMS. THE BALLOON RUPTURED AT 6 ATMS ON THE THIRD INFLATION. THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING¿ CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032104080 13825540

    Patients

    Seq Age Sex Outcome Treatment
    1 BALLOON CATHETER - 7 MM STERING