BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS

    MDR report key: 2060170 · Received April 15, 2011

    Report

    Report Number
    3005099803-2011-01226
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K924608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BUT AN EVALUATION HAS NOT YET BEEN PERFORMED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THE EVENT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT. ANALYSIS OF THE RETURNED DEVICE SHOWED THAT THE PROXIMAL END OF THE STENT WAS BROKEN, AND THE DETACHED FRAGMENT WAS INCLUDED WITH THE RETURN. THE INVESTIGATION DETERMINED THAT THE TEAR IS CONSISTENT WITH THOSE CAUSED BY THE SUTURE. THE SUTURE WAS NOT PRESENT WITH THE RETURN; THEREFORE, IT WAS NOT POSSIBLE TO DETERMINE HOW THE SUTURE BECAME DETACHED. PER THE EVENT INFORMATION, THE DEFECT WAS IDENTIFIED WHILE UNPACKING; THEREFORE, HANDLING DAMAGE LIKELY CONTRIBUTED TO THE EVENT. THE LOT NUMBER OF THE RETURNED DEVICE WAS 13922991.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDROGEL COATED PERCUFLEX DRAINAGE CATHETER WAS ATTEMPTED TO BE USED IN AN UNKNOWN PROCEDURE ON (B)(6), 2011. (PATIENT ID, AGE, WEIGHT AND SEX ARE UNKNOWN) ACCORDING TO THE COMPLAINANT, UPON UNPACKING THE DEVICE, THE STENT BROKE WHILE IT WAS BEING TAKEN OUT OF THE PACKAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL PATIENT AND EVENT INFORMATION. HOWEVER, NO FURTHER EVENT DETAILS HAVE BEEN MADE AVAILABLE TO BOSTON SCIENTIFIC TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDROGEL COATED PERCUFLEX DRAINAGE CATHETER WAS ATTEMPTED TO BE USED IN AN UNKNOWN PROCEDURE ON (B)(6), 2011. (PATIENT ID, AGE, WEIGHT AND SEX ARE UNKNOWN) ACCORDING TO THE COMPLAINANT, UPON UNPACKING THE DEVICE, THE STENT BROKE WHILE IT WAS BEING TAKEN OUT OF THE PACKAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL PATIENT AND EVENT INFORMATION. HOWEVER, NO FURTHER EVENT DETAILS HAVE BEEN MADE AVAILABLE TO BOSTON SCIENTIFIC TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M006175253050 0013974460

    Patients

    Seq Age Sex Outcome Treatment
    1