BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARCATH

    MDR report key: 1994399 · Received February 17, 2011

    Report

    Report Number
    2134265-2011-00283
    Event Type
    Malfunction
    Date Received
    February 17, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    DQY
    PMA / PMN Number
    K022061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE CATHETER AND INFLATION UNIT WERE RECEIVED BACK IN OVER ALL GOOD PHYSICAL CONDITION. THE DOWNLOADED DATA FROM THE INFLATION UNIT SHOWS ONE GOOD TREATMENT RUN WAS COMPLETED AND THEN ABOUT 16 MINUTES LATER TWO ADDITIONAL TREATMENT CYCLES WERE COMPLETED WITH NO ERROR CODES RECORDED. THE INFLATION UNIT WAS TESTED WITH A KNOWN GOOD TEST CATHETER AND COMPLETED TWO FULL TREATMENT CYCLES WITH NO ERRORS. THE CATHETER WAS THREADED WITH A GUIDEWIRE WITH NO PROBLEMS. THE BALLOON WAS CONNECTED TO THE RETURNED INFLATION UNIT AND COMPLETED TWO FULL TREATMENT CYCLES WITH NO ERRORS. THE CATHETER WAS PRESSURIZED TO 50 PSI AND NO LEAKS WERE FOUND IN THE INNER OR OUTER BALLOONS, FUSION JUNCTIONS OF THE BALLOONS, GUIDEWIRE LUMEN, SHAFT, MANIFOLD OR CONNECTOR ASSEMBLIES. VACUUM WAS DRAWN AT THE CONCLUSION OF EACH TREATMENT CYCLE USING A 20CC SYRINGE PER THE DFU INSTRUCTIONS AND THE BALLOON COMPRESSED/DEFLATED AS EXPECTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL AND/OR PROCEDURAL FACTORS. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. SINCE FIRST MARKETED, NO DESIGN OR STERILIZATION CHANGES WERE MADE RELATED TO THE REFERENCED EVENT OF BALLOON DEFLATION FAILURE. THE CATHETER AND INFLATION UNIT WERE RECEIVED BACK IN OVER ALL GOOD PHYSICAL CONDITION. THE DOWNLOADED DATA FROM THE INFLATION UNIT SHOWS ONE GOOD TREATMENT RUN WAS COMPLETED AND THEN ABOUT 16 MINUTES LATER TWO ADDITIONAL TREATMENT CYCLES WERE COMPLETED WITH NO ERROR CODES RECORDED. THE INFLATION UNIT WAS TESTED WITH A KNOWN GOOD TEST CATHETER AND COMPLETED TWO FULL TREATMENT CYCLES WITH NO ERRORS. THE CATHETER WAS THREADED WITH A GUIDEWIRE WITH NO PROBLEMS. THE BALLOON WAS CONNECTED TO THE RETURNED INFLATION UNIT AND COMPLETED TWO FULL TREATMENT CYCLES WITH NO ERRORS. THE CATHETER WAS PRESSURIZED TO 50 PSI AND NO LEAKS WERE FOUND IN THE INNER OR OUTER BALLOONS, FUSION JUNCTIONS OF THE BALLOONS, GUIDEWIRE LUMEN, SHAFT, MANIFOLD OR CONNECTOR ASSEMBLIES. VACUUM WAS DRAWN AT THE CONCLUSION OF EACH TREATMENT CYCLE USING A 20CC SYRINGE PER THE DFU INSTRUCTIONS AND THE BALLOON COMPRESSED/DEFLATED AS EXPECTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL AND/OR PROCEDURAL FACTORS. A TREND ANALYSIS COVERING A 15-MONTH PERIOD ((B)(4), 2009 TO (B)(4) 2011) WAS PERFORMED FOR POLARCATH PERIPHERAL DILATATION CATHETER BALLOON DEFLATION FAILURE COMPLAINTS. THE ANALYSIS DISPLAYED A TOTAL OF (B)(4) COMPLAINTS, ONE (1) OF WHICH WAS DETERMINED TO BE MDR REPORTABLE. INCLUSION OF THESE COMPLAINTS IN THE TREND ANALYSIS CONSISTED OF SIMILAR FAILURE MODES COMBINED WITH THE PRODUCT FAMILY. THE REPORTED COMPLAINTS WERE NOT ASSOCIATED WITH AN ADVERSE TREND. TABLE 1 - POLARCATH PERIPHERAL DILATION CATHETER BALLOON DEFLATION FAILURE COMPLAINTS: (B)(4), PRODUCT FAMILY: POLARCATH PERIPHERAL DILATION CATHETER, MDR ACCESS #: 2134265-2011-00283. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH #: (B)(4). IT WAS REPORTED THAT DURING A CRYOPLASTY TREATMENT PROCEDURE, A DEFLATION FAILURE OCCURRED. THE 65% RE-STENOSISED LESION WAS LOCATED IN A BYPASS GRAFT IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT FEMORAL POPLITEAL ARTERY. THE PHYSICIAN ADVANCED THE .014 POLARCATH BALLOON TO THE LESION AND COMPLETED A TREATMENT CYCLE AND THEN ATTACHED A 20CC SYRINGE TO DEFLATE THE BALLOON. A LEAKING SOUND WAS HEARD SO THEY THOUGHT THAT THE BALLOON HAD NOT DEFLATED. A 60CC SYRINGE WAS ATTACHED TO COMPLETE DEFLATION BUT THEY COULD STILL HEAR THE LEAKING SOUND. THEY WERE STILL UNSURE IF THE BALLOON WAS DEFLATED, BUT REMOVED THE BALLOON WITHOUT ANY DIFFICULTIES. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH #: (B)(4). IT WAS REPORTED THAT DURING A CRYOPLASTY TREATMENT PROCEDURE, A DEFLATION FAILURE OCCURRED. THE 65% RE-STENOSISED LESION WAS LOCATED IN A BYPASS GRAFT IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT FEMORAL POPLITEAL ARTERY. THE PHYSICIAN ADVANCED THE .014 POLARCATH BALLOON TO THE LESION AND COMPLETED A TREATMENT CYCLE AND THEN ATTACHED A 20CC SYRINGE TO DEFLATE THE BALLOON. A LEAKING SOUND WAS HEARD SO THEY THOUGHT THAT THE BALLOON HAD NOT DEFLATED. A 60CC SYRINGE WAS ATTACHED TO COMPLETE DEFLATION BUT THEY COULD STILL HEAR THE LEAKING SOUND. THEY WERE STILL UNSURE IF THE BALLOON WAS DEFLATED, BUT REMOVED THE BALLOON WITHOUT ANY DIFFICULTIES. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARCATH CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - SAN JOSE M001T3040135010 13769054

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR POLARCATH INFLATION UNIT| BALKAN SHEATH, 5.5