BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS¿ VASCULAR SD

    MDR report key: 2800436 · Received October 22, 2012

    Report

    Report Number
    2134265-2012-06425
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 26, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAIL. FOR EVAL, RETURNED TO MFR. ON, DEVICE RETURNED TO MFR, DEVICE EVALUATED BY MFR, EVAL SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES: UPDATED. DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED DEVICE REVEALED SHAFT KINKS 5.5 AND 9CM FROM THE DISTAL TIP. THERE WAS NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE THAT THE DAMAGE WAS ATTRIBUTABLE TO ANY PRODUCT QUALITY DEFICIENCIES. 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

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE CONCENTRIC, 80% STENOSED TARGET LESION WAS LOCATED WITHIN A GRAFT ANASTOMOSIS IN THE RENAL ARTERY. PREDILATION WAS NOT PERFORMED. WHILE ADVANCING THE 5.0X15MM EXPRESS VASCULAR SD STENT SYSTEM, THE SHAFT BROKE, BUT REMAINED INTACT. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE CONCENTRIC, 80% STENOSED TARGET LESION WAS LOCATED WITHIN A GRAFT ANASTOMOSIS IN THE RENAL ARTERY. PREDILATION WAS NOT PERFORMED. WHILE ADVANCING THE 5.0X15MM EXPRESS VASCULAR SD STENT SYSTEM, THE SHAFT BROKE, BUT REMAINED INTACT. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS¿ VASCULAR SD CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74937917515150 15142308

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR