BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE?

    MDR report key: 3242600 · Received July 23, 2013

    Report

    Report Number
    3005099803-2013-06920
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. REPORTED EVENT OF HYDROPHILIC TIP DETACHMENT, EXPOSING DISTAL TIP OF METAL COREWIRE. THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE HAVE NOT YET DETERMINED THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION REVEALED THAT THE PEBAX SECTION WAS DAMAGED EXPOSING THE TIP OF THE CORE WIRE. NO EVIDENCE OF CORE WIRE FRACTURED. PTFE DID NOT PRESENT ANY ANOMALY. THE COMPLAINT IS CONSISTENT WITH THE RETURN THAT THE PEBAX SECTION WAS DAMAGED EXPOSING THE TIP OF THE CORE WIRE. IT IS MOST LIKELY THAT THE HANDLING OF THE DEVICE DURING UNPACKING AND THE PREPARATION MAY HAVE CONTRIBUTED TO THE DEVICE DAMAGE, THEREFORE THE MOST PROBABLE ROOT CAUSE IS HANDLING DAMAGE. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE REPORTED LOT NUMBER 15901218.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING A PLACEMENT OF ESOPHAGUS STENT PROCEDURE. PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE HYDROPHILIC TIP OF THE GUIDEWIRE DETACHED/SEPARATED, EXPOSING THE DISTAL TIP OF THE METAL CORE WIRE. THE PROCEDURE WAS COMPLETED WITH A NEW JAGWIRE GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING A PLACEMENT OF ESOPHAGUS STENT PROCEDURE. PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE HYDROPHILIC TIP OF THE GUIDEWIRE DETACHED/SEPARATED, EXPOSING THE DISTAL TIP OF THE METAL CORE WIRE. THE PROCEDURE WAS COMPLETED WITH A NEW JAGWIRE GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342312 JAGWIRE? STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00556621 15901218

    Patients

    Seq Age Sex Outcome Treatment
    1