BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRAJAGWIRE

    MDR report key: 2091867 · Received May 17, 2011

    Report

    Report Number
    3005099803-2011-01717
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 23, 2011
    Report Date
    April 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE TIP OF THE DEVICE HAD DETACHED. THE GUIDEWIRE WAS ALSO FOUND TO BE KINKED, HOWEVER THERE WAS NO DAMAGE NOTED TO THE CORE WIRE. IT IS IMPORTANT TO MENTION THAT THE EVENT HAPPENED DURING THE PROCEDURE AND THERE IS NO ALLEGED DAMAGE IN THE WIRE PRIOR TO ITS INSERTION. IT IS POSSIBLE THAT UNSTATED PROCEDURE AND POSSIBLY CLINICAL FACTORS MAY HAVE CONTRIBUTED TO THE POLY TIP DAMAGE AND THE BENDS FOUND, INCLUDING BUT NOT LIMITED TO INTERACTION WITH OTHER DEVICES, HANDLING OF THE DEVICE AND CONDITION OF THE TREATED LESION. ADDITIONALLY THE REMNANTS OF ADHESIVE FOUND INDICATE THAT THE POLY TIP WAS PROPERLY ATTACHED TO THE COREWIRE. "OPERATIONAL CONTEXT" IS THE MOST PROBABLE ROOT CAUSE FOR THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2011-01718 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO HYDRAJAG GUIDEWIRES WERE USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE OF THE COMMON BILE DUCT PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE THE TIPS OF THE GUIDEWIRES DETACHED WHILE THEY WERE BEING WITHDRAWN. THE DETACHED TIPS WERE RECOVERED USING AN EXTRACTOR RETRIEVAL BALLOON. IT IS IMPORTANT TO NOTE THAT BOTH GUIDEWIRES WERE BEING USED PAST THEIR EXPIRATION DATES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT GUIDEWIRE WITH NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS "STABLE."

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-01717 ADDRESSES THIS GUIDEWIRE. REFER TO MANUFACTURER REPORT # 3005099803-2011-01718 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO HYDRAJAG GUIDEWIRES WERE USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE OF THE COMMON BILE DUCT PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE THE TIPS OF THE GUIDEWIRES DETACHED WHILE THEY WERE BEING WITHDRAWN. THE DETACHED TIPS WERE RECOVERED USING AN EXTRACTOR RETRIEVAL BALLOON. IT IS IMPORTANT TO NOTE THAT BOTH GUIDEWIRES WERE BEING USED PAST THEIR EXPIRATION DATES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT GUIDEWIRE WITH NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRAJAGWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA M00556051 11239270

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention EXTRACTOR BALLOON