BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY BALLOON DILATATION CATHETER

    MDR report key: 2071899 · Received April 28, 2011

    Report

    Report Number
    3005099803-2011-01426
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K910931
    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 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

    VISUAL EVALUATION OF THE RETURNED COMPLAINT DEVICE REVEALED A KINK IN THE CATHETER; THE BALLOON WAS RETURNED PARTIALLY INFLATED WITH CLEAR LIQUID. DEFLATION OF THE BALLOON USING AN ENCORE INFLATION UNIT WAS ATTEMPTED, HOWEVER THE BALLOON COULD NOT BE DEFLATED. THE DEVICE WAS THEN IMMERSED IN WARM WATER TO DISSOLVE ANY DRIED CONTRAST MEDIA INHIBITING DEFLATION OF THE BALLOON; HOWEVER DEFLATION WAS STILL UNSUCCESSFUL. THE SHAFT WAS THEN CUT INTO SECTIONS IN AN ATTEMPT TO LOCATE THE BLOCKAGE. THE SHAFT WAS FIRST CUT 100MM DISTAL TO STRAIN RELIEF. THE BALLOON WAS GENTLY COMPRESSED AND IT REMAINED INFLATED. THE SHAFT WAS THEN CUT 400MM DISTAL TO THE END OF THE SHAFT. THE BALLOON WAS GENTLY COMPRESSED AND IT REMAINED INFLATED. THE SHAFT WAS THEN CUT 450MM DISTAL TO THE END OF THE SHAFT. THE BALLOON WAS GENTLY COMPRESSED AND IT REMAINED INFLATED. THE SHAFT WAS THEN CUT 350MM DISTAL TO THE END OF THE SHAFT. THE BALLOON WAS GENTLY COMPRESSED AND IT REMAINED INFLATED. A FINAL CUT WAS MADE 30MM DISTAL TO THE PROXIMAL BOND AND THE CONTRAST MEDIA FLOWED OUT OF THE BALLOON WHEN IT WAS GENTLY COMPRESSED. MICROSCOPIC EXAMINATION OF THE FINAL 10MM SECTION OF THE SHAFT REVEALED A SMALL KINK AND A BLOCKAGE. FURTHER ANALYSIS OF THIS SECTION OF THE DEVICE USING X-RAY TOMOGRAPHY AND 3D IMAGES CONFIRMED THAT THE BLOCKAGE NOTED INSIDE THE LUMEN OF THE SHAFT WAS NOT POLYMER MATERIAL BUT MOST LIKELY SOLIDIFIED CONTRAST MEDIA. BASED ON THE CONDITION OF THE RETURNED INCIDENT DEVICE, THE COMPLAINT THAT THE BALLOON WOULD NOT DEFLATE WAS CONFIRMED. AN OCCLUSION, MOST LIKELY SOLIDIFIED CONTRAST MEDIA, INHIBITED DEFLATION OF THE BALLOON DURING DEVICE EVALUATION. THEREFORE THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS OPERATIONAL CONTEXT; THIS FAILURE OCCURS WHEN ANATOMICAL OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE LIMIT THE PERFORMANCE OF THE DEVICE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT A MAXFORCE BILIARY BALLOON DILATATION CATHETER WAS USED DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATATION (EPBD) PROCEDURE OF THE COMMON BILE DUCT PERFORMED ON (B)(6), 2011 (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS COMPLETED WITH THIS DEVICE; HOWEVER, AFTER DILATATION THE BALLOON WOULD NOT DEFLATE. THE BALLOON WAS ABLE TO BE WITHDRAWN THROUGH THE ENDOSCOPE. 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. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT AND PROCEDURE INFORMATION HAVE BEEN UNSUCCESSFUL. 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), 2011 THAT A MAXFORCE BILIARY BALLOON DILATATION CATHETER WAS USED DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATATION (EPBD) PROCEDURE OF THE COMMON BILE DUCT PERFORMED ON (B)(6), 2011 (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS COMPLETED WITH THIS DEVICE; HOWEVER, AFTER DILATATION THE BALLOON WOULD NOT DEFLATE. THE BALLOON WAS ABLE TO BE WITHDRAWN THROUGH THE ENDOSCOPE. 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. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT AND PROCEDURE INFORMATION HAVE BEEN UNSUCCESSFUL. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BILIARY BALLOON DILATATION CATHETER CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00567380 14039784

    Patients

    Seq Age Sex Outcome Treatment
    1