BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVH

    MDR report key: 9033727 · Received September 13, 2019

    Report

    Report Number
    2242352-2019-01026
    Event Type
    Injury
    Date Received
    September 13, 2019
    Date of Event
    August 18, 2019
    Report Date
    September 13, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: D4, G4, G7, H2, H3, H4, H6, H10. ADD D-4 EXP DATE ADD H-4 MANUFACTURE DATE TRACKWISE ID (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. AN INVESTIGATION WAS CONDUCTED ON 09/24/2019. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED. BLOOD WAS OBSERVED ON THE HARVESTING HANDLE. BLOOD AND CHARRED TISSUE WAS OBSERVED ON THE HEATER WIRE. MICROSCOPIC INSPECTION OF THE HEATER WIRE WAS CONDUCTED. THE HEATER WIRE WAS OBSERVED TO BE SLIGHTLY FLEXED AWAY FROM THE HOT JAW, BUT REMAINED ATTACHED AT THE BASE AND TIP OF THE HOT JAW. THE SILICONE INSULATION ON BOTH THE COLD AND HOT JAWS WAS OBSERVED TO BE INTACT, NO VISUAL PEELING OF SILICONE WAS OBSERVED. BASED ON THE RETURNED CONDITION OF THE DEVICE, THE REPORTED FAILURE "PEELED JAW" WAS NOT CONFIRMED, BUT WAS CONFIRMED FOR THE ANALYZED FAILURE "MATERIAL TWISTED/ BENT WIRE". A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WERE NO NCMR¿S FOR THE REPORTED LOT NUMBER.

    Additional Manufacturer Narrative · 0

    CORRECTED SECTIONS; A4; FROM "KGS" TO "LBS" B5: THE EVENT DESCRIPTION WAS CORRECTED TO MIRROR THE PARENT COMPLAINT EVENT DESCRIPTION SUMMARY H10: INVESTIGATION SUMMARY WAS CORRECTED BELOW TO "PEELED; CANNULA SHAVINGS" TRACKWISE ID # (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. AN INVESTIGATION WAS CONDUCTED ON 09/24/2019. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED. BLOOD WAS OBSERVED ON THE HARVESTING HANDLE. BLOOD AND CHARRED TISSUE WAS OBSERVED ON THE HEATER WIRE. MICROSCOPIC INSPECTION OF THE HEATER WIRE WAS CONDUCTED. THE HEATER WIRE WAS OBSERVED TO BE SLIGHTLY FLEXED AWAY FROM THE HOT JAW, BUT REMAINED ATTACHED AT THE BASE AND TIP OF THE HOT JAW. THE SILICONE INSULATION ON BOTH THE COLD AND HOT JAWS WAS OBSERVED TO BE INTACT, NO VISUAL PEELING OF SILICONE WAS OBSERVED. NO EVIDENCE OF SHAVINGS WERE OBSERVED ON THE JAWS. THE CANNULA WAS NOT RETURNED FOR EVALUATION. A MECHANICAL EVALUATION WAS CONDUCTED USING A REFERENCE CANNULA. THE HEMOPRO DEVICE WAS INSERTED INTO THE CANNULA, NO SHAVINGS WERE OBSERVED. BASED ON THE RETURNED CONDITION OF THE DEVICE, THE REPORTED FAILURE "PEELED; CANNULA; SHAVING" WAS NOT CONFIRMED, BUT WAS CONFIRMED FOR THE ANALYZED FAILURE "MATERIAL TWISTED/ BENT WIRE".

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO, THEY NOTICED THAT THE HP DEVICE JAWS HAD SEPARATED PART OF THE SILICON ON THE NON BURNING SIDE. A PIECE HAD FALLEN OFF THE JAW. THE ACCOUNT OPENED THE INCISION MORE AND FLUSHED THE TUNNEL OUT PROFUSELY, WAS UNABLE TO FIND THE PIECE. THEY OPENED UP ANOTHER KIT AND FINISHED THE CASE. AT THIS TIME THERE HAS BEEN NO PATIENT AFFECTS.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO, THEY NOTICED THAT THE HP DEVICE JAWS HAD SEPARATED PART OF THE SILICONE ON THE NON BURNING SIDE. A PIECE HAD FALLEN OFF THE JAW. THE PIECE THAT WAS SEEN THAT CAME OFF INTO THE LEG WAS A "SHAVED" PORTION OF THE WHITE TOOL PORT (HEMOPRO) INNER SHAFT (CANNULA).THE ACCOUNT OPENED THE INCISION MORE AND FLUSHED THE TUNNEL OUT PROFUSELY, WAS UNABLE TO FIND THE PIECE. THEY OPENED UP ANOTHER KIT AND FINISHED THE CASE. AT THIS TIME THERE HAS BEEN NO PATIENT AFFECTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO, THEY NOTICED THAT THE HP DEVICE JAWS HAD SEPARATED PART OF THE SILICON ON THE NON BURNING SIDE. A PIECE HAD FALLEN OFF THE JAW. THE ACCOUNT OPENED THE INCISION MORE AND FLUSHED THE TUNNEL OUT PROFUSELY, WAS UNABLE TO FIND THE PIECE. THEY OPENED UP ANOTHER KIT AND FINISHED THE CASE. AT THIS TIME THERE HAS BEEN NO PATIENT AFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817105 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO (US) VH-3000 25147275

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention