BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRE¿ WIREGUIDED

    MDR report key: 2732914 · Received September 7, 2012

    Report

    Report Number
    3005099803-2012-04003
    Event Type
    Death
    Date Received
    September 7, 2012
    Date of Event
    August 6, 2012
    Report Date
    August 10, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KNQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510K NUMBER IS K112994.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS UNKNOWN. THE EXACT PATIENT DEATH DATE IS UNKNOWN. HOWEVER, IT WAS REPORTED THAT IT OCCURRED BETWEEN (B)(6) 2012. THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. THE 510K NUMBER IS K112994. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2012 THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED DURING AN ENDOSCOPIC PAPILLARY LARGE BALLOON DILATATION (EPLBD) PROCEDURE ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, AS THE PAPILLA WAS DILATED, THE PATIENT DEVELOPED A LARGE HEMORRHAGE. BECAUSE OF THIS, THE PROCEDURE WAS NOT COMPLETED. THE PHYSICIAN DID NOT BELIEVE THAT THE HEMORRHAGE WAS CAUSED BY ANY MALFUNCTION OF THE DEVICE, BUT WAS RATHER A RESULT OF PROCEDURAL COMPLICATIONS AND PATIENT RISK FACTORS. ON AUGUST 20, 2012, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT HAD DEVELOPED A SUBARACHNOID HEMORRHAGE BETWEEN AUGUST 7, 2012 AND AUGUST 8, 2012 AND SUBSEQUENTLY PASSED AWAY. THE DATE OF DEATH IS UNKNOWN, HOWEVER IT WAS REPORTED TO BE BETWEEN AUGUST 13, 2012 AND AUGUST 15, 2012. IN THE PHYSICIAN'S ASSESSMENT, THE SUBARACHNOID HEMORRHAGE WAS NOT DIRECTLY RELATED TO THE HEMORRHAGE THAT OCCURRED DURING THE PROCEDURE; HOWEVER, THE HEMORRHAGIC SHOCK CAUSED BY PROCEDURAL COMPLICATIONS MIGHT HAVE CAUSED A CASCADE OF EVENTS THAT STIMULATED THE HEMORRHAGE IN THE BRAIN. IT WAS CONFIRMED ON SEPTEMBER 12, 2012 THAT NO AUTOPSY RESULTS ARE AVAILABLE TO BOSTON SCIENTIFIC CORPORATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2012 THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED DURING AN ENDOSCOPIC PAPILLARY LARGE BALLOON DILATATION (EPLBD) PROCEDURE ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, AS THE PAPILLA WAS DILATED, THE PATIENT DEVELOPED A LARGE HEMORRHAGE. BECAUSE OF THIS, THE PROCEDURE WAS NOT COMPLETED. THE PHYSICIAN DID NOT BELIEVE THAT THE HEMORRHAGE WAS CAUSED BY ANY MALFUNCTION OF THE DEVICE, BUT WAS RATHER A RESULT OF PROCEDURAL COMPLICATIONS AND PATIENT RISK FACTORS. ON (B)(6) 2012, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT HAD DEVELOPED A SUBARACHNOID HEMORRHAGE BETWEEN (B)(6) 2012 AND (B)(6) 2012 AND SUBSEQUENTLY PASSED AWAY. THE DATE OF DEATH IS UNKNOWN, HOWEVER IT WAS REPORTED TO BE BETWEEN (B)(6) 2012 AND (B)(6) 2012. IN THE PHYSICIAN'S ASSESSMENT, THE SUBARACHNOID HEMORRHAGE WAS NOT DIRECTLY RELATED TO THE HEMORRHAGE THAT OCCURRED DURING THE PROCEDURE; HOWEVER, THE HEMORRHAGIC SHOCK CAUSED BY PROCEDURAL COMPLICATIONS MIGHT HAVE CAUSED A CASCADE OF EVENTS THAT STIMULATED THE HEMORRHAGE IN THE BRAIN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING WHETHER OR NOT AN AUTOPSY WAS DONE HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE¿ WIREGUIDED BALLOON DILATOR KNQ BOSTON SCIENTIFIC - CORK M00558710

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death