BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER

    MDR report key: 866760 · Received June 15, 2007

    Report

    Report Number
    6000093-2007-01180
    Event Type
    Malfunction
    Date Received
    June 15, 2007
    Report Date
    May 17, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    PMA / PMN Number
    K050389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED PRODUCT ANALYSIS VERIFIED THAT THE CATHETER WAS DEFECTIVE. THE BALLOON CATHETER WITH THE BALLOON IN A DEFLATED STATE WAS RECEIVED AND AN INNER SHAFT SEPARATION, SHAFT DAMAGE AND NUMEROUS SHAFT KINKS WERE OBSERVED. THE INNER SHAFT WITHIN THE BALLOON EXHIBITED A KINK AND THE PROXIMAL MARKER BAND HAD MOVED DISTALLY WITHIN THE BALLOON. THE INNER SHAFT SEPARATION WAS LOCATED 4 MILLIMETERS DISTALLY FROM THE WIRE PORT. VISUAL AND MICROSCOPIC EXAMINATION OF THE MATERIAL SURROUNDING THE INNER SHAFT SEPARATION DID NOT REVEAL ANY INHERENT MATERIAL DEFICIENCIES THAT WOULD HAVE CONTRIBUTED TO THE SEPARATION. VISUAL AND MICROSCOPIC EXAMINATION OF THE MATERIAL SURROUNDING THE AXIAL COMPRESSION DAMAGE (ACCORDION FOLDING) DID NOT REVEAL ANY INHERENT MATERIAL DEFICIENCIES THAT WOULD HAVE CONTRIBUTED TO THE DAMAGE. FURTHER EXAMINATION OF THE MATERIAL SURROUNDING THE SHAFT KINKS DID NOT REVEAL ANY MATERIAL ABNORMALITIES THAT WOULD HAVE CONTRIBUTED TO THE KINKS. THE INNER SHAFT SEPARATION, ACCORDION FOLDING AND THE PROXIMAL MARKER BAND MOVEMENT DAMAGE IS CONSISTENT WITH THE CATHETER BEING SUBJECTED TO GUIDE WIRE MOVEMENT DIFFICULTIES. AS THE COMPLAINT DESCRIPTION ONLY STATES THE BALLOON IS DEFECTIVE AND THAT THERE IS NO ADDITIONAL INFORMATION REGARDING DIFFICULTIES EXPERIENCED DURING THE PROCEDURE, THE EXACT CAUSE OF THE CATHETER DAMAGE COULD NOT BE DETERMINED. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 8852841 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE OF THE REPORTED COMPLAINT IS UNKNOWN.

    Description of Event or Problem · 1

    EVENT DETERMINED TO BE REPORTABLE BASED UPON ANALYSIS APPROVED IN 2007. IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY PROCEDURE, THE BALLOON OF THE ULTRA-SOFT SV CATHETER WAS DEFECTIVE. DEVICE ANALYSIS REVEALED AN INNER SHAFT SEPARATION, ACCORDION FOLDING AND PROXIMAL MARKER BAND MOVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC 3.0/3.0/140 8852841

    Patients

    Seq Age Sex Outcome Treatment
    1 YR