BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-SOFT SV BALLOON

    MDR report key: 738219 · Received July 7, 2006

    Report

    Report Number
    6000093-2006-01259
    Event Type
    Malfunction
    Date Received
    July 7, 2006
    Date of Event
    June 8, 2006
    Report Date
    June 8, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SOURCE CONFIRMED THAT THE PRODUCT HAD BEEN DISPOSED AND NO ANALYSIS WAS POSSIBLE. BATCH NUMBER 8463018 WAS REPORTED IN ERROR, THIS BATCH NUMBER DOES NOT MATCH THE UPN FOR THIS COMPLAINT. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 8181659 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 CAUSE OF THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTERNAL CAROTID ARTERY PTA TREATMENT PROCEDURE, BALLOON DEFLATION DIFFICULTIES WERE ENCOUNTERED. THE ULTRA-SOFT SV BALLOON WAS TRACKED OVER A CORDIS ANGIOGUARD DEVICE AND WAS USED TO POSTDILATE A CORDIS ANGIOGUARD DEVICE AND WAS USED TO POSTDILATE A CORDIS PRECISE STENT. THE BALLOON INFLATED WELL WITH AN INFLATION DEVICE, HOWEVER, IT "DID NOT DEFLATE AS IT SHOULD." THE PHYSICIAN ATTEMPTED TO DEFLATE THE BALLOON WITH A SYRINGE, BUT WAS AGAIN UNSUCCESSFUL. HE WAS, HOWEVER, ABLE TO SAFELY REMOVE THE BALLOON THROUGH THE SHEATH. WHEN HE EXAMINED THE BALLOON OUTSIDE OF THE PATIENT'S BODY, IT APPEARED TO DEFLATE INTO A FLAT CONFIGURATION, RATHER THAN PROPERLY REWRAPPING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE AND "NO HARM WAS DONE TO THE PATIENT." PATIENT STATUS IS REPORTED AS "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-SOFT SV BALLOON PTA BALLOON CATHETER LIT BOSTON SCIENTIFIC CORPORATION NA 8181659

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN