BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREFACE® GUIDING SHEATH WITH POSTERIOR CURVE

    MDR report key: 2963699 · Received February 15, 2013

    Report

    Report Number
    2029046-2013-00014
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 28, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4). IT WAS REPORTED THAT DURING A PROCEDURE, WHILE INSERTING THE DILATOR THROUGH THE SHEATH THE USER EXPERIENCED RESISTANCE APPROXIMATELY 3 CM FROM THE DISTAL END OF THE SHEATH. EXTRA FORCE WAS APPLIED TO ALLOW THE DILATOR TO PASS THROUGH THE CATHETER TIP. UPON INSPECTION, THE DILATOR LOOKED FRAYED. THIS WAS ENCOUNTERED BEFORE THE CATHETER WAS USED ON THE PATIENT. THE SHEATH WAS EXCHANGED. THE CASE CONTINUED WITHOUT ANY FURTHER ISSUE. UPON RECEIVING, THE UNIT WAS INSPECTED AND IT WAS OBSERVED THAT THE VESSEL WAS TORN AND ONE SHEATH PURGE HOLE WAS DAMAGED. ALSO, SOME CLEAR CRYSTALS WERE OBSERVED. THE CRYSTALS WERE NO LONGER IN THE SHEATH AFTER DECONTAMINATION THEREFORE THE ORIGIN REMAINS UNKNOWN. A SEM ANALYSIS WAS PERFORMED. THE SEM RESULTS SHOWED THE SHEATH PRESENTED EVIDENCE OF INTERNAL ABRASION CAUSED BY AN EXTERNAL FORCE. IN ADDITION, THE VESSEL DILATOR PRESENTED A TORN SECTION, CAUSED BY A RESISTANCE DURING THE INTRODUCTION. IT IS POSSIBLE THAT THE VESSEL DILATOR COULD GET STUCK ON THE SIDE HOLE AND THEREFORE THE DAMAGE ON BOTH PIECES OCCURRED. THE VESSEL DILATOR WAS INTRODUCED INTO THE SHEATH AND IT PASSED THROUGH WITHOUT ANY COMPLICATION. THE SHAPE MASTER COMPARISON WAS PERFORMED AND THE SHEATH INTRODUCER WAS NOT WITHIN THE LIMITS DUE TO THE WAVED CONDITION OBSERVED. HOWEVER ,THE VESSEL DILATOR WAS FOUND WITHIN THE ALLOWED LIMITS. THE INTERNAL DIAMETER FOR THE SHEATH INTRODUCER AND EXTERNAL DIAMETER FOR THE VESSEL DILATOR WERE MEASURED AND BOTH WERE WITHIN SPECIFICATIONS THE DEVICE HISTORY RECORD (DHR) 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. ALL DEVICES ARE INSPECTED FOR DEFECTS BEFORE PACKAGING. ON LINE INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF DAMAGE/DEFECT FROM LEAVING THE FACILITY. THE CUSTOMER COMPLAINT ABOUT THE RESISTANCE CANNOT BE CONFIRMED. HOWEVER, IT MIGHT BE DUE TO THE FACT THE VESSEL GOT STUCK ON THE PURGE HOLES.

    Additional Manufacturer Narrative · 1

    BWI'S ORIGINAL EXTERNAL MANUFACTURER (OEM) FOR THIS PRODUCT IS: CORDIS DE MEXICO (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, WHILE INSERTING THE DILATOR THROUGH THE SHEATH USER EXPERIENCED RESISTANCE APPROXIMATELY 3 CM FROM THE DISTAL END OF THE SHEATH. EXTRA FORCE WAS APPLIED TO ALLOW THE DILATOR TO PASS THROUGH THE CATHETER TIP. UPON INSPECTION, THE DILATOR LOOKED FRAYED. THIS WAS ENCOUNTERED BEFORE THE CATHETER WAS USED ON THE PATIENT. THE SHEATH WAS EXCHANGED. THE CASE CONTINUED WITHOUT ANY FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67335 PREFACE® GUIDING SHEATH WITH POSTERIOR CURVE INTRODUCER, CATHETER DYB BIOSENSE WEBSTER, INC (IRWINDALE) 301803P OEM_301803P

    Patients

    Seq Age Sex Outcome Treatment
    1