BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 6888399 · Received September 22, 2017

    Report

    Report Number
    3002648230-2017-00528
    Event Type
    Malfunction
    Date Received
    September 22, 2017
    Date of Event
    December 9, 2014
    Report Date
    December 9, 2014
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT SUMMARY: THE PATIENT DATA FILES DID NOT SHOW ANY SYSTEM NOTICES FOR THE DATE OF EVENT. FILES ALSO SHOWED AT LEAST FOURTEEN INJECTIONS WERE PERFORMED WITH CATHETER 2AF284 / 70009-62. UPON VISUAL INSPECTION OF FLEXCATH ADVANCE SHEATH 4FC12 / 39914-18, RESULTS SHOWED THE DEVICE WAS INTACT WITH NO APPARENT ISSUES. THE REPORTED LEAKING VALVE/AIR INGRESS COULD NOT BE REPRODUCED. MULTIPLE ASPIRATIONS / INJECTIONS WERE PERFORMED WITHOUT AIR BUBBLES OR LEAKS; HEMOSTATIC VALVE WAS LEAK TIGHT. A CLINICAL ISSUE OCCURRED AND WAS RESOLVED DURING PROCEDURE (ST ELEVATION / EMBOLISM). IN CONCLUSION, THE REPORTED ISSUE (AIR INGRESS) HAS NOT BEEN CONFIRMED THROUGH TESTING. A CLINICAL EVENT OCCURRED DURING PROCEDURE. FLEXCATH ADVANCE 4FC12 / 39914-18 PASSED THE RETURNED PRODUCT INSPECTION AS PER SPECIFICATION. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, ISOLATION OF THE PVS WAS CONDUCTED USING THE ARCTIC FRONT ADVANCE (NUMBER OF ABLATIONS PERFORMED: THREE TIMES TO LSPV, TWO TIMES TO LIPV, TWO TIMES TO RSPV, TWO TIMES TO RIPV). AFTER THAT, THE SHEATH WAS PULLED TO THE RA AND CTI WAS TREATED USING A COMPETITOR PRODUCT. TO CHECK THE POTENTIALS IN THE PVS, THE SHEATH WAS INSERTED INTO THE LA AND THE MAPPING CATHETER ONLY WAS PLACED IN THE SHEATH. DISAPPEARANCE OF POTENTIALS WAS CHECKED IN THE FOLLOWING ORDER: LSPV, THE LIPV AND THEN RIPV. ECG SHOWED ST ELEVATION IN THE RIPV. CAG WAS THEREFORE CONDUCTED. NEITHER STENOSIS NOR AIR WAS CONFIRMED THERE. TEN MINUTES LATER, ST LEVEL WENT BACK TO NORMAL. AIR WAS FOUND BELOW THE PA VALVE THROUGH FLUOROSCOPY DURING THE CAG PERFORMING. WHEN THE MAPPING CATHETER WAS INSERTED IN THE SHEATH, NEGATIVE PRESSURE WAS GIVEN TO FLUSH THE SHEATH, BUT NO FURTHER AIR WAS FOUND. THE PATIENT'S CONSCIOUS LEVEL WAS NORMAL. NO ABNORMALITY WAS CONFIRMED IN HIS VISUAL FIELD OR MOVEMENTS OF THE LIMBS AND BODY. THE PATIENT HAD NO BREATHING DIFFICULTY EITHER. THE CASE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667848 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12 39914

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening