BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 1900718 · Received November 16, 2010

    Report

    Report Number
    2134265-2010-05036
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 20, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A VESSEL DISSECTION OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY (SFA). VASCULAR ACCESS WAS OBTAINED VIA THE LEFT BRACHIAL ARTERY. A 300CM V-18 CONTROL GUIDE WIRE WAS ADVANCED AND A NON-BSC 4FR 140CM GUIDE CATHETER WAS ALSO ADVANCED AND USED TO SUPPORT THE V-18 GUIDE WIRE, HOWEVER, THE V-18 COULD NOT CROSS THE LESION. THE WIRE WAS EXCHANGED TO A NON-BSC DEVICE. NEXT, A 4MM X 60MM STERLING BALLOON CATHETER WAS ADVANCED TO PRE-DILATE THE LESION. A 50% RESIDUAL STENOSIS REMAINED. THE PHYSICIAN THEN AN ADVANCED THE 6.0MM X 100MM STERLING BALLOON CATHETER ACROSS THE LESION AND INFLATED THE DEVICE AN UNSPECIFIED NUMBER OF TIMES USING UNSPECIFIED ATMS. A CONTRAST STUDY WAS PERFORMED AND A 10CM DISSECTION WAS NOTED DISTAL TO THE LESION IN THE LEFT SFA. THE PHYSICIAN TREATED THE DISSECTION BY INFLATING THE 6.0MM X 100MM STERLING BALLOON CATHETER TO 3 ATMS FOR A "LONG INFLATION", AND IMPLANTED TWO NON-BSC STENTS (6MM X 60MM AND A 6MM X 40MM) TO COMPLETE THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032601010 13770522

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INTRODUCER SHEATH: DESTINATION 6FR 90CM TERUMO| BALLOON CATHETER: STERLING OTW 4MM X 60MM| MICRO-CATHETER: 4FR 140CM GOODMAN| GUIIDE WIRE: V-18 CONTROL WIRE| GUIDE WIRE: TREASURE