BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE

    MDR report key: 2962119 · Received February 14, 2013

    Report

    Report Number
    2029046-2013-00013
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    December 5, 2012
    Report Date
    January 9, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DYB
    PMA / PMN Number
    K982740
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO REQUEST FOR THE COMPLAINT PRODUCT TO BE RETURNED FOR ANALYSIS. PRODUCT WAS NOT RETURNED FOR INVESTIGATION AS INITIALLY REPORTED.SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING THE PROCEDURE WHEN THE SURGEON TRIED TO ACCESS TO FEMORAL VEIN WITH DILATOR. THE SURGEON PERCEIVED SOMETHING LIKE A STEP BETWEEN THE TIP OF THE PREFACE AND THE DILATOR THAT DIDN'T PERMIT AN EASY ACCESS. THE SURGEON FELT THE SENSATION THAT USING MORE FORCE THE VEIN COULD BE SPRAINED. THE PROCEDURE WAS COMPLETED BY USING A NON BWI DILATOR AND INTRODUCER. ADDITIONAL INFORMATION PROVIDED ON (B)(4) 2013 STATED THE DISTAL PART OF THE TRANSSEPTAL NEEDLE WAS NOT TAPERED HOWEVER THE TRANSITION FROM THE DILATOR AND THE SHEATH IS NOT SMOOTH ENOUGH TO ALLOW AN EASY INSERTION OVER THE WIRE AND INTO THE SEPTUM. DUE TO THIS THE TRANSSEPTAL WOULD BE MORE DIFFICULT TO BE INSERTED IN THE VEIN. BASED ON THE ADDITIONAL INFORMATION THIS COMPLAINT WAS DETERMINED TO BE MDR REPORTABLE. THE SHEATH INTRODUCER WAS RECEIVED FOR ANALYSIS. THE VESSEL DILATOR WAS NOT RECEIVED; HOWEVER, A TEST SAMPLE WAS USED FOR THE FUNCTIONAL TEST. IT WAS OBSERVED THAT THE SHEATH INTRODUCER PRESENTED EVIDENCE OF THREE KINKS AT 33CM, 35CM AND 46CM FROM TIP OF THE SHEATH INTRODUCER. A FUNCTIONAL TEST WAS PERFORMED AND A SLIGHT FRICTION WAS FELT DUE TO THE KINKS ON THE SHEATH INTRODUCER. HOWEVER, THE VESSEL DILATOR PASSED WITHOUT ANY DIFFICULTY THROUGH THE LENGTH OF THE SHEATH INTRODUCER. IN ADDITION, THE SHAPE MASTER COMPARISON WAS PERFORMED AND IT WAS OBSERVED THAT SHEATH INTRODUCER WAS WITHIN THE ALLOWED LIMITS. THE INTERNAL DIAMETER FOR THE SHEATH INTRODUCER WAS MEASURED AT THREE DIFFERENT SECTIONS AND THE MEASUREMENTS INDICATE THE INTERNAL DIAMETER IS WITHIN SPECIFICATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE WHEN THE SURGEON TRIED TO ACCESS TO FEMORAL VEIN WITH DILATOR. THE SURGEON PERCEIVED SOMETHING LIKE A STEP BETWEEN THE TIP OF THE PREFACE AND THE DILATOR THAT DIDN'T PERMIT AN EASY ACCESS. THE SURGEON FELT THE SENSATION THAT USING MORE FORCE THE VEIN COULD BE SPRAINED. THE PROCEDURE WAS COMPLETED BY USING A NON BWI DILATOR AND INTRODUCER. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2013 STATED THE DISTAL PART OF THE TRANSSEPTAL NEEDLE WAS NOT TAPERED HOWEVER THE TRANSITION FROM THE DILATOR AND THE SHEATH IS NOT SMOOTH ENOUGH TO ALLOW AN EASY INSERTION OVER THE WIRE AND INTO THE SEPTUM. DUE TO THIS THE TRANSSEPTAL WOULD BE MORE DIFFICULT TO BE INSERTED IN THE VEIN. BASED ON THE ADDITIONAL INFORMATION THIS COMPLAINT WAS DETERMINED TO BE MDR REPORTABLE. THE ALERT DATE WAS RESET TO (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66032 PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE INTRODUCER, CATHETER DYB BIOSENSE WEBSTER, INC (IRWINDALE) 301803M OEM_301803M

    Patients

    Seq Age Sex Outcome Treatment
    1