BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK BALLOON CATHETER

    MDR report key: 2022133 · Received March 17, 2011

    Report

    Report Number
    2134265-2011-00735
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE WAS RECEIVED IN TWO PIECES. THE FRACTURE OCCURRED 2MM FROM EDGE OF STRAIN RELIEF. DRIED BLOOD AND CONTRAST WERE VISIBLE IN THE BALLOON AND INFLATION LUMEN. THE DEVICE WAS SOAKED IN WARM WATER TO ATTEMPT TO DISLODGE THE HARDENED MATERIAL AND ALLOW INFLATION OF THE BALLOON. HOWEVER; DUE TO THE AMOUNT OF THE HARDENED MATERIAL STILL INSIDE THE LUMEN, IT PREVENTED INFLATION OF THE DEVICE AND POSITIVE IDENTIFICATION OF ANY DAMAGE CONSISTENT WITH THE REPORTED BALLOON BURST. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE CALCIFICATION WAS SEVERE AND THAT THE BALLOON WAS INFLATED TO 20ATMS FOR 4-5 SECONDS ON THE THIRD INFLATION AND RUPTURED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH ACUTE CORONARY SYNDROME. THE 60% STENOTIC, 4.0X16MM DE NOVO, AND ECCENTRIC LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN DIRECT STENTED WITH AN UNSPECIFIED STENT AND THEN ADVANCED THE 2.75X8MM QUANTUM MAVERICK BALLOON TO THE STENT TO POST DILATE, BUT THE BALLOON BROKE. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.75X8MM QUANTUM MAVERICK BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH ACUTE CORONARY SYNDROME. THE 60% STENOTIC, 4.0X16MM DE NOVO, AND ECCENTRIC LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN DIRECT STENTED WITH AN UNSPECIFIED STENT AND THEN ADVANCED THE 2.75X8MM QUANTUM MAVERICK BALLOON TO THE STENT TO POST DILATE, BUT THE BALLOON BROKE. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.75X8MM QUANTUM MAVERICK BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808008270 13539886

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR JL GUIDE CATHETER| BMW GUIDE WIRE