BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRAJAGWIRE

    MDR report key: 2022618 · Received March 17, 2011

    Report

    Report Number
    3005099803-2011-00827
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE PEBAX AT THE TIP HAD PARTIALLY DETACHED FROM THE COREWIRE. THE COREWIRE EXPOSED WAS SLIGHTLY SCRAPPED AT THE JAG END SECTION AND REMNANTS OF ADHESIVE WERE FOUND INDICATING THAT THE PEBAX WAS PROPERLY ATTACHED TO THE COREWIRE. ALSO THE SECTION BETWEEN THE FLARE AND JAG END SECTION WAS SEVERELY DAMAGED, IT APPEARS HAS BEEN PULLED AGAINST RESISTANCE. THE DEVICE APPEARS TO HAVE BEEN IN CONTACT WITH A SHARP OR METAL OBJECT. THE FRICTION CREATED BY OTHER DEVICES INVOLVED IN THE PROCEDURE MAY HAVE CONTRIBUTED THE PEBAX TO BECOME DAMAGED ASSOCIATED WITH THE USE AND/OR HANDLING OF THE DEVICE DURING THE PROCEDURE. BASED ON THE FACT THAT THE EVENT REPORTED WAS DURING THE INSERTION AND THERE IS NO ALLEGED DAMAGE IN THE WIRE PRIOR TO ITS INSERTION, ADDITIONALLY THE REMNANTS OF ADHESIVE FOUND INDICATE THAT THE PEBAX WAS PROPERLY ATTACHED TO THE COREWIRE. THE MOST PROBABLE ROOT CAUSE IS "CAUSED BY OTHER DEVICE" A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND. LABELING REVIEW PERFORMED AND NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRAJAG GUIDEWIRE WAS USED DURING A DRAINAGE OF A PANCREATIC CYST ON (B)(6) 2011. ACCORDING TO THE COMPLAINT, THE HYDRAJAG GUIDEWIRE WAS INSERTED INTO AN FNA NEEDLE AND BOTH WERE INSERTED INTO THE PANCREATIC CYST ABOUT 15CM. THE NEEDLE WAS THEN REMOVED AND AN ERCP CANNULA WAS ADVANCED OVER THE GUIDEWIRE. AFTER ERCP, THE PHYSICIAN ATTEMPTED TO INSERT A DILATOR, BUT ENCOUNTERED RESISTANCE. THE DILATOR WAS REMOVED AND AN ENDOSCOPIC NASOPANCREATIC DRAINAGE TUBE (ENPD) WAS INSERTED. THE ENPD TUBE ALSO ENCOUNTERED RESISTANCE AND WAS REMOVED. AS A RESULT, THE PHYSICIAN ATTEMPTED TO ADVANCE THE DILATOR AGAIN, HOWEVER, AGAIN THE DILATOR ENCOUNTERED RESISTANCE. THE PHYSICIAN THEN ATTEMPTED TO INSERT A CANNULA, BUT THIS TOO MET RESISTANCE. DURING THIS ATTEMPT TO ADVANCE THE CANNULA, THE CANNULA SWIRLED AND THE TIP OF THE GUIDEWIRE DETACHED IN THE BAG OF THE PANCREAS. THE DETACHED TIP WAS CONFIRMED UNDER FLUOROSCOPY. THE PROCEDURE WAS THEN ABANDONED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT HAD "NO ISSUES" FOLLOWING THE PROCEDURE. THE PROCEDURE HAS BEEN RESCHEDULED FOR (B)(6). THE CYST HAS BECOME SMALLER AND THE SITE IS PLANNING ON CUTTING THE PANCREAS CYST AND REMOVING THE GUIDEWIRE FRAGMENT FROM THE PATIENT PERCUTANEOUSLY. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. UPDATE: (B)(6) 2011. THE PROCEDURE HAS BEEN POSTPONED INDEFINITELY. IT IS UNKNOWN WHEN IT IS GOING TO BE , OR IF IT IS GOING TO BE, RESCHEDULED. UPDATE: (B)(6) 2011. THE TIP HAS NOT PASSED THROUGH THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRAJAG GUIDEWIRE WAS USED DURING A DRAINAGE OF A PANCREATIC CYST ON (B)(6) 2011. ACCORDING TO THE COMPLAINT, THE HYDRAJAG GUIDEWIRE WAS INSERTED INTO AN FNA NEEDLE AND BOTH WERE INSERTED INTO THE PANCREATIC CYST ABOUT 15CM. THE NEEDLE WAS THEN REMOVED AND AN ERCP CANNULA WAS ADVANCED OVER THE GUIDEWIRE. AFTER ERCP, THE PHYSICIAN ATTEMPTED TO INSERT A DILATOR, BUT ENCOUNTERED RESISTANCE. THE DILATOR WAS REMOVED AND AN ENDOSCOPIC NASOPANCREATIC DRAINAGE TUBE (ENPD) WAS INSERTED. THE ENPD TUBE ALSO ENCOUNTERED RESISTANCE AND WAS REMOVED. AS A RESULT, THE PHYSICIAN ATTEMPTED TO ADVANCE THE DILATOR AGAIN, HOWEVER, AGAIN THE DILATOR ENCOUNTERED RESISTANCE. THE PHYSICIAN THEN ATTEMPTED TO INSERT A CANNULA, BUT THIS TOO MET RESISTANCE. DURING THIS ATTEMPT TO ADVANCE THE CANNULA, THE CANNULA SWIRLED AND THE TIP OF THE GUIDEWIRE DETACHED IN THE BAG OF THE PANCREAS. THE DETACHED TIP WAS CONFIRMED UNDER FLUOROSCOPY. THE PROCEDURE WAS THEN ABANDONED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT HAD "NO ISSUES" FOLLOWING THE PROCEDURE. THE PROCEDURE HAS BEEN RESCHEDULED FOR (B)(6). THE CYST HAS BECOME SMALLER AND THE SITE IS PLANNING ON CUTTING THE PANCREAS CYST AND REMOVING THE GUIDEWIRE FRAGMENT FROM THE PATIENT PERCUTANEOUSLY. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. UPDATE (B)(6) 2011. THE PROCEDURE HAS BEEN POSTPONED INDEFINITELY. IT IS UNKNOWN WHEN IT IS GOING TO BE, OR IF IT IS GOING TO BE, RESCHEDULED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRAJAG GUIDEWIRE WAS USED DURING A DRAINAGE OF A PANCREATIC CYST ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, THE HYDRAJAG GUIDEWIRE WAS INSERTED INTO AN FNA NEEDLE AND BOTH WERE INSERTED INTO THE PANCREATIC CYST ABOUT 15CM. THE NEEDLE WAS THEN REMOVED AND AN ERCP CANNULA WAS ADVANCED OVER THE GUIDEWIRE. AFTER ERCP, THE PHYSICIAN ATTEMPTED TO INSERT A DILATOR, BUT ENCOUNTERED RESISTANCE. THE DILATOR WAS REMOVED AND AN ENDOSCOPIC NASOPANCREATIC DRAINAGE TUBE (ENPD) WAS INSERTED. THE ENPD TUBE ALSO ENCOUNTERED RESISTANCE AND WAS REMOVED. AS A RESULT, THE PHYSICIAN ATTEMPTED TO ADVANCE THE DILATOR AGAIN, HOWEVER, AGAIN THE DILATOR ENCOUNTERED RESISTANCE. THE PHYSICIAN THEN ATTEMPTED TO INSERT A CANNULA, BUT THIS TOO MET RESISTANCE. DURING THIS ATTEMPT TO ADVANCE THE CANNULA, THE CANNULA SWIRLED AND THE TIP OF THE GUIDEWIRE DETACHED IN THE BAG OF THE PANCREAS. THE DETACHED TIP WAS CONFIRMED UNDER FLUOROSCOPY. THE PROCEDURE WAS THEN ABANDONED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT HAD "NO ISSUES" FOLLOWING THE PROCEDURE. THE PROCEDURE HAS BEEN RESCHEDULED FOR THE END OF MARCH. THE CYST HAS BECOME SMALLER AND THE SITE IS PLANNING ON CUTTING THE PANCREAS CYST AND REMOVING THE GUIDEWIRE FRAGMENT FROM THE PATIENT PERCUTANEOUSLY. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRAJAGWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA M00556051 13743167

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention COOK FNA NEEDLE| COOK 5FR ENDOSCOPIC NASOPANCREATIC DRAINAGE TUBE| OLYMPUS WING CHIP CANNULA| COOK 6FR DILATOR