BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYSCOPE ACCESS AND DELIVERY CATHETER

    MDR report key: 2031855 · Received March 28, 2011

    Report

    Report Number
    3005099803-2011-01041
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    ODF
    PMA / PMN Number
    K090170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER, AGE/DATE OF BIRTH, GENDER, AND WEIGHT ARE UNKNOWN. HOWEVER, PATIENT (B)(6). 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 FOUND THAT THE PEBAX WAS CUT IN THREE PLACES NEAR THE DISTAL TIP. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE SHEATH WAS TORN NEAR THE TIP. THE EVALUATION ATTRIBUTED THIS FAILURE TO THE MANUFACTURING PROCESS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS SUPPLIER MANUFACTURE. AN INVESTIGATION IS UNDERWAY TO ADDRESS THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SYNSCOPE ACCESS AND DELIVERY CATHETER WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, WHILE PREPARING FOR THE PROCEDURE, THE DEVICE WAS REMOVED FROM THE PACKAGE AND THE CATHETER SHEATH WAS FOUND TO BE TORN NEAR THE TIP OF THE SPY CATHETER. NO DAMAGE TO THE PACKAGE WAS VISIBLE. THE CASE WAS COMPLETED WITH ANOTHER SPYSCOPE ACCESS AND DELIVERY CATHETER. 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE ACCESS AND DELIVERY CATHETER WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, WHILE PREPARING FOR THE PROCEDURE, THE DEVICE WAS REMOVED FROM THE PACKAGE AND THE CATHETER SHEATH WAS FOUND TO BE TORN NEAR THE TIP OF THE SPY CATHETER. NO DAMAGE TO THE PACKAGE WAS VISIBLE. THE CASE WAS COMPLETED WITH ANOTHER SPYSCOPE ACCESS AND DELIVERY CATHETER. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPYSCOPE ACCESS AND DELIVERY CATHETER MINI ENDOSCOPE, GASTROENTEROLOGY-UROLOGY ODF BOSTON SCIENTIFIC - MARLBOROUGH M00546230 1ML0102601

    Patients

    Seq Age Sex Outcome Treatment
    1