BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHAPERON GUIDING CATHETER SYSTEM (6F)

    MDR report key: 8714695 · Received June 19, 2019

    Report

    Report Number
    2032493-2019-00155
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Date of Event
    May 16, 2019
    Report Date
    May 20, 2019
    Manufacturer
    MICROVENTION, INC.
    Product Code
    DQY
    UDI-DI
    00810170013157
    PMA / PMN Number
    K082385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT RELEASE DECISION CONTROL SHEET OF THE INVOLVED PRODUCT/LOT# CONFIRMED THAT THERE WERE NOT ANY INDICATIONS OF ANOMALIES. A SEARCH OF COMPLAINT FILES DID NOT FIND ANY SIMILAR REPORT WITH THE INVOLVED PRODUCT/LOT# COMBINATION. VISUAL INSPECTION UPON RECEIPT FOUND THAT THE PEEL PACK HAD AN OPENING APPROX. 60MM IN LENGTH ON THE LOCATION AROUND THE HUB OF THE INNER CATHETER PACKED IN THE PEEL PACK, WHERE THE FILM HAD BEEN SEPARATED FROM THE NONWOVEN FABRIC. THERE WAS NOT ANY OTHER ANOMALY, SUCH AS A BREAK OR SEPARATION OF THE MATERIALS, ON THE REMAINDERS OF THE PEEL PACK. THE INNER SURFACES OF THE SEPARATED FILM AND NONWOVEN FABRIC WERE ELECTRON MICROSCOPICALLY INSPECTION. ON THE SURFACE OF THE FILM SOME TRANSCRIBED FIBER PATTERNS OF THE NONWOVEN FABRIC WERE NOTED. THE NONWOVEN FABRIC WAS FOUND TO HAVE THE EVIDENCE OF ADHESIVE APPLIED THERE. THESE STATES WERE CONFIRMED TO BE COMPARABLE TO THOSE OF THE SEPARATED FILM AND NONWOVEN FABRIC OF A CURRENT PEEL PACK SAMPLE. THE SEALING STRENGTH OF THE ACTUAL PEEL PACK SAMPLE WAS CONFIRMED TO MEET THE SPECIFICATION. A TEST TO REPRODUCE THE ISSUE WAS CONDUCTED. THE DIFFERENCE IN THE ATMOSPHERIC PRESSURE DURING THE TRANSPORTATION BEING TAKEN INTO CONSIDERATION, A TEST SAMPLE FROM THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS INFLATED BY APPLYING AN AIR PRESSURE INSIDE THE PEEL PACK AND PUT INTO THE UNIT BOX. THIS SAMPLE WAS THEN EXPOSED TO SHOCK FORCE BY DROPPING A LOAD ON IT. AS THE RESULT, AN OPENING WAS GENERATED ON THE LOCATION AROUND THE HUB OF THE INNER CATHETER PACKED IN THE PEEL PACK, WHERE THE FILM HAD BEEN SEPARATED FROM THE NONWOVEN FABRIC. THE STATE WAS CONFIRMED TO BE VERY SIMILAR TO THAT OF THE ACTUAL SAMPLE AS ONE OF THE POSSIBILITIES, THE FOLLOWING SCENARIO CAN BE INFERRED: DUE TO THE DIFFERENCE IN THE ATMOSPHERIC PRESSURE DURING TRANSPORTATION TO THE WAREHOUSE, THE PEEL PACK OF THE ACTUAL SAMPLE BECAME SWOLLEN INSIDE THE UNIT BOX. IN THIS STATE, THE ACTUALSAMPLE WAS SUBJECTED TO SHOCK FORCE WHICH EXCEEDED THE SEALING STRENGTH OF THE PEEL PACK, RESULTING IN THE GENERATION OF THE OPENING. FROM THE AVAILABLE INFORMATION, HOWEVER, IT IS DIFFICULT TO DETERMINE THE CAUSE OF THIS COMPLAINT DEFINITELY.

    Additional Manufacturer Narrative · 0

    PRIOR TO SHIPMENT OF THE DEVICE TO THE MANUFACTURER, TWO PHOTOGRAPHS WERE PROVIDED OF THE DEVICE, WHICH DEMONSTRATED A 5CM OPEN POUCH SEAL AT THE SIDE, EXPOSING THE DEVICE WITHIN THE POUCH. THE DEVICE WAS RECEIVED FOR EVALUATION AT THE MANUFACTURING FACILITY ON JUNE 16, 2019. THE RESULTS OF THE PRODUCT INVESTIGATION HAVE NOT YET BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER; IT WAS FORWARDED TO TERUMO, AS THEY ARE THE ACTUAL DEVICE MANUFACTURER. THE INVESTIGATION OF THE DEVICE AND A REVIEW OF THE LOT INFORMATION IS UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INNER PACKING BAG CONTAINING THE STERILE DEVICE WAS UNSEALED FOR A LENGTH OF APPROXIMATELY 5 CM. THE DEVICE ISSUE WAS DISCOVERED IN THE WAREHOUSE PRIOR TO DISTRIBUTION TO A CUSTOMER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505525 CHAPERON GUIDING CATHETER SYSTEM (6F) GUIDING CATHETER DQY MICROVENTION, INC. GC695M2VT 180528 00810170013157

    Patients

    Seq Age Sex Outcome Treatment
    1