BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXFORCE¿

    MDR report key: 2231912 · Received September 1, 2011

    Report

    Report Number
    3005099803-2011-02913
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K910931
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THIS IS BOTH A PRODUCT PROBLEM AND AN ADVERSE EVENT. INVESTIGATION RESULTS. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO VISIBLE ISSUES WITH THE CATHETER. HOWEVER, FUNCTIONAL TEST REVEALED A PINHOLE IN THE BALLOON MATERIAL. THE INVESTIGATION RESULTS ARE CONSISTENT WITH THE EVENT DESCRIPTION. THE REPORTED DEFECT OF BALLOON PINHOLE WAS CONFIRMED. THIS FAILURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE PERFORMANCE OF THE BALLOON. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A REVIEW OF THE DFU REVEALED THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO A SECOND EVENT THAT OCCURRED DURING THE SAME PROCEDURE REPORTED IN MANUFACTURER REPORT # 3005099803-2011-02938. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT A MAXFORCE BILIARY BALLOON DILATATION CATHETER WAS USED DURING A DILATATION PROCEDURE IN THE COMMON BILE DUCT (CBD) ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE THE NURSE PASSED THE MAXFORCE BALLOON OVER THE JAGWIRE INTO THE STRICTURE. AS THE BALLOON INCREASED IN PRESSURE THE BALLOON DEVELOPED A PINHOLE. IT WAS CONFIRMED THAT THE BALLOON DID NOT BURST AND NO PIECES DETACHED INSIDE THE PATIENT. THERE WAS NO SECOND ATTEMPT TO DILATE THE DUCT BUT THE PHYSICIAN PLACED A PLASTIC STENT IN THE PLACE OF THE STRICTURE IN THE CBD. THE NEXT DAY, THE PHYSICIAN EXAMINED THE PATIENT WHO WAS EXPERIENCING VOMITING, NAUSEA, AND A STOMACH ACHE. THE PHYSICIAN DISCOVERED THROUGH SONOGRAPHY THAT THERE WAS FLUID IN THE ABDOMEN, AROUND THE LIVER. DIRECT SAMPLING (PUNCTURE) CONFIRMED THAT THE FLUID WAS BILE. WHEN ASKED ABOUT THE ORIGIN OF THE FLUID, THE PHYSICIAN STATED THAT IT WAS UNKNOWN BUT GUESSED THAT A MICRO-PERFORATION WAS FORMED IN THE CBD AS A RESULT OF THE "STREAM" FROM THE PINHOLE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GETTING BETTER" DAYS AFTER THE INCIDENT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO A SECOND EVENT THAT OCCURRED DURING THE SAME PROCEDURE REPORTED IN MANUFACTURER REPORT # 3005099803-2011-02938. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT A MAXFORCE BILIARY BALLOON DILATATION CATHETER WAS USED DURING A DILATATION PROCEDURE IN THE COMMON BILE DUCT (CBD) ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE THE NURSE PASSED THE MAXFORCE BALLOON OVER THE JAGWIRE INTO THE STRICTURE. AS THE BALLOON INCREASED IN PRESSURE THE BALLOON DEVELOPED A PINHOLE. IT WAS CONFIRMED THAT THE BALLOON DID NOT BURST AND NO PIECES DETACHED INSIDE THE PATIENT. THERE WAS NO SECOND ATTEMPT TO DILATE THE DUCT BUT THE PHYSICIAN PLACED A PLASTIC STENT IN THE PLACE OF THE STRICTURE IN THE CBD. THE NEXT DAY, THE PHYSICIAN EXAMINED THE PATIENT WHO WAS EXPERIENCING VOMITING, NAUSEA, AND A STOMACH ACHE. THE PHYSICIAN DISCOVERED THROUGH SONOGRAPHY THAT THERE WAS FLUID IN THE ABDOMEN, AROUND THE LIVER. DIRECT SAMPLING (PUNCTURE) CONFIRMED THAT THE FLUID WAS BILE. WHEN ASKED ABOUT THE ORIGIN OF THE FLUID, THE PHYSICIAN STATED THAT IT WAS UNKNOWN BUT GUESSED THAT A MICRO-PERFORATION WAS FORMED IN THE CBD AS A RESULT OF THE "STREAM" FROM THE PINHOLE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GETTING BETTER" DAYS AFTER THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXFORCE¿ CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00567340 13124892

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization