BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-THIN¿ DIAMOND¿

    MDR report key: 2810100 · Received October 31, 2012

    Report

    Report Number
    2134265-2012-06681
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 3, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K960501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. 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).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT VASCULAR ACCESS WAS OBTAINED VIA A VENOUS APPROACH. THE 80% STENOSED TARGET LESION WAS LOCATED IN A VESSEL THAT WAS NON-CALCIFIED AND NON-TORTUOUS. THERE WERE A TOTAL OF THREE ATTEMPTS MADE TO DEFLATE THE BALLOON. THERE WAS NO DAMAGE TO THE STENT THAT OCCURRED WHEN THE BALLOON CATHETER WAS BEING PULLED TO REMOVE. THE ULTRA-THIN DIAMOND BALLOON WAS REMOVED FROM THE PATIENT INTACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DIALYSIS GRAFT DECLOT PROCEDURE, BALLOON DEFLATION AND REMOVAL ISSUES OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUBCLAVIAN VEIN. THIS 12-4/5.8/75 ULTRA-THIN DIAMOND BALLOON CATHETER WAS ADVANCED BEYOND ANOTHER MANUFACTURERS IMPLANTED STENT. THE ULTRA-THIN DIAMOND BALLOON WAS INFLATED TO NOMINAL PRESSURE. THE BALLOON WAS THEN ATTEMPTED TO DEFLATE, BUT IT DID NOT FULLY DEFLATE. THERE WAS DIFFICULTY WITHDRAWING THE BALLOON DEVICE PASSED THE STENT. THE ULTRA-THIN DIAMOND BALLOON WAS INFLATED ONCE AGAIN AND THEN DEFLATED WITH A SYRINGE. THE BALLOON CATHETER WAS PULLED HARD WHEN ATTEMPTING TO WITHDRAW AND THOUGH THE STENT DID NOT MIGRATE, THE BALLOON DID CATCH ON THE STENT STRUT WHILE REMOVING. THE ULTRA-THIN DIAMOND BALLOON WAS REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-THIN¿ DIAMOND¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY M001165330 0014806293

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT: GORE