BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR? PRO RX

    MDR report key: 3222681 · Received July 12, 2013

    Report

    Report Number
    3005099803-2013-06845
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 20, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    FGE
    PMA / PMN Number
    K102082
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. (B)(4) FOR THE REPORTED EVENT OF CATHETER CRACKED. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS RECEIVED, THEREFORE THE DEVICE EXPIRATION AND MANUFACTURED DATES ARE NOW KNOWN. VISUAL EVALUATION WAS PERFORMED AND NO DEFECTS WERE NOTED. WATER WAS INJECTED INTO THE INJECT LUMEN BUT WOULD NOT PASS DUE TO CRYSTALLIZED CONTRAST BLOCKING THE INJECT LUMEN. THE CONTRAST WAS DISSOLVED. WATER WAS AGAIN INJECTED AND EXITED AT THE RAMP. THE RAMP AREA OF THE CATHETER WAS ANALYZED AND A CUT IN THE GUIDEWIRE LUMEN WHICH DISSECTED THE INTERLUMEN WALL INTO THE INJECT LUMEN WAS FOUND. SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS VERIFIED THE CUT DIMENSION IS CONSISTENT WITH THE BLADE TIP DIMENSION WHICH WAS USED TO REMOVE THE BEADING FROM THIS LUMEN. THE NOTED CUT CAUSED IN AN INTERLUMEN LEAK; HOWEVER THERE WAS NO DAMAGE/CRACK TO THE OUTSIDE OF THE CATHETER AS WAS INITIALLY REPORTED. THEREFORE, THIS IS NO LONGER A REPORTABLE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. BASED ON THE INVESTIGATION RESULTS AND AVAILABLE INFORMATION, THE ROOT CAUSE OF THIS EVENT IS RELATED TO MANUFACTURING AND ACTIONS HAVE BEEN TAKEN TO FURTHER INVESTIGATION THE EXACT CAUSE OF THE FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO WAS USED DURING A STONE REMOVAL PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHILE REMOVING STONES IT WAS NOTICED THAT THE CATHETER OF THE DEVICE WAS BROKEN AND CONTRAST LEAKED FROM THE CRACK ON THE CATHETER. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO WAS USED DURING A STONE REMOVAL PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHILE REMOVING STONES IT WAS NOTICED THAT THE CATHETER OF THE DEVICE WAS BROKEN AND CONTRAST LEAKED FROM THE CRACK ON THE CATHETER. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321918 EXTRACTOR? PRO RX CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - CORK M00547010 0015905530

    Patients

    Seq Age Sex Outcome Treatment
    1