BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING?

    MDR report key: 4151759 · Received October 8, 2014

    Report

    Report Number
    2134265-2014-05960
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A STERLING BALLOON CATHETER. THERE WAS CONTRAST IN THE INFLATION LUMEN AND BLOOD BETWEEN THE BALLOON FOLDS. THE BALLOON WAS TIGHTLY FOLDED. MICROSCOPIC EXAMINATION INSPECTION PRESENTED NO DAMAGE OR IRREGULARITIES IN THE BALLOON MATERIAL. MICROSCOPIC EXAMINATION AND TACTILE INSPECTION REVEALED NUMEROUS KINKS PROXIMAL OF THE EXIT NOTCH. MICROSCOPIC EXAMINATION PRESENTED NO DAMAGE OR IRREGULARITIES IN THE TIP. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. NO OTHER ISSUES OR DAMAGE WERE IDENTIFIED DURING THE PRODUCT 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATHETER REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. AFTER AN UNSPECIFIED SIZE V18 GUIDE WIRE CROSSED THE LESION, A 6.0MMX20MMX135CM STERLING¿ BALLOON CATHETER WAS ADVANCED OVER THE AORTIC BIFURCATION IN A CONTRALATERAL APPROACH HOWEVER THE BALLOON CATHETER WOULD NOT TRACK UP AND MOVE DOWN. THE CATHETER BECAME LODGED. THE DEVICE STARTED PUSHING UP AND BECAME STUCK IN THE ABDOMINAL AORTA. THE PHYSICIAN WAS ABLE TO REMOVE THE BALLOON CATHETER SUCCESSFULLY USING ADDITIONAL FORCE. THE PROCEDURE WAS COMPLETED USING A NON BSC OVER-THE-WIRE (OTW) BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATHETER REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. AFTER AN UNSPECIFIED SIZE V18 GUIDE WIRE CROSSED THE LESION, A 6.0MMX20MMX135CM STERLING¿ BALLOON CATHETER WAS ADVANCED OVER THE AORTIC BIFURCATION IN A CONTRALATERAL APPROACH HOWEVER THE BALLOON CATHETER WOULD NOT TRACK UP AND MOVE DOWN. THE CATHETER BECAME LODGED. THE DEVICE STARTED PUSHING UP AND BECAME STUCK IN THE ABDOMINAL AORTA. THE PHYSICIAN WAS ABLE TO REMOVE THE BALLOON CATHETER SUCCESSFULLY USING ADDITIONAL FORCE. THE PROCEDURE WAS COMPLETED USING A NON BSC OVER-THE-WIRE (OTW) BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632439 STERLING? CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031602010 16999900

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: V18 GUIDE WIRE