BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFLEX (TM)

    MDR report key: 2211325 · Received August 15, 2011

    Report

    Report Number
    2134265-2011-03351
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 16, 2011
    Report Date
    July 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RECEIVED IN TWO SECTIONS AS A RESULT OF A BREAK IN THE MIDSHAFT. THE BREAK WAS LOCATED AT 2.7CM DISTAL TO THE PROXIMAL EDGE OF THE MIDSHAFT. THE HYPOTUBE WAS SEVERELY KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. NO ISSUES WERE NOTED WITH THE PROFILES OF THE CRIMPED STENT, BALLOON AND TIP SECTIONS OF THIS DEVICE. THE CRIMPED STENT WAS SECURED IN ITS CORRECT POSITION ON THE BALLOON. DEVICE ANALYSIS OF THE RETURNED DEVICE DETERMINED THAT THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT INCIDENT, AS THE STENT WAS REPORTED TO HAVE DISLODGED, BUT WAS FOUND TO BE FULLY CRIMPED ON THE BALLOON. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREP FOR A STENTING PROCEDURE TREATMENT THE VERIFLEX (MR) US 32MM 4.50 STENT SLIPPED OFF THE DELIVERY SYSTEM. THE LESION BEING TREATED WAS IN THE RIGHT CORONARY ARTERY. WHEN THE SCRUB NURSE PULLED ON THE PLASTIC SLEEVE PROTECTOR THAT COVERS THE STENT, IT SLIPPED OFF. THIS OCCURRED OUTSIDE THE BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE WITH SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS WAS LISTED AS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREP FOR A STENTING PROCEDURE TREATMENT THE VERIFLEX (MR) US 32MM 4.50 STENT SLIPPED OFF THE DELIVERY SYSTEM. THE LESION BEING TREATED WAS IN THE RIGHT CORONARY ARTERY. WHEN THE SCRUB NURSE PULLED ON THE PLASTIC SLEEVE PROTECTOR THAT COVERS THE STENT, IT SLIPPED OFF. THIS OCCURRED OUTSIDE THE BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE WITH SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS WAS LISTED AS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX (TM) STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893432450 14330543

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR