BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVE MAPPING CATHETER

    MDR report key: 2192025 · Received August 4, 2011

    Report

    Report Number
    3007798852-2011-00003
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    MDT ABLATION FRONTIERS MFG
    Product Code
    DRF
    PMA / PMN Number
    K102588
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS VISUALLY INSPECTED. THE INSPECTION SHOWED THAT THE SHAFT WAS BROKEN AT THE PROXIMAL END ATTACHMENT WITH THE ECG CONNECTOR. NO ECG SIGNAL WIRES WERE BROKEN INSIDE THE SHAFT. THIS OUT OF SPECIFICATION DOES NOT RELATE TO THE REPORTED ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. RESULTS OF EVALUATION OF RETURNED DEVICE WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    A CRYOABLATION PROCEDURE WAS PERFORMED USING THE ARCTIC FRONT CATHETER, ACHIEVE MAPPING CATHETER AND FLEXCATH STEERABLE SHEATH. THE PHYSICIAN MOVED TO THE RIPV TO ISOLATE THAT VEIN. IN AN ATTEMPT TO POSITION THE ARCTIC FRONT CATHETER, THE FLEXCATH WAS INADVERTENTLY PULLED INTO THE RIGHT ATRIUM (RA). THE PHYSICIAN GENTLY TRIED TO RE-ADVANCE THE FLEXCATH INTO THE LEFT ATRIUM (LA) TO NO AVAIL. THE ARCTIC FRONT CATHETER WAS REMOVED FROM THE SHEATH AND THE PHYSICIAN PUT THE FLEXCATH DILATOR AND 0.035/260 J WIRE BACK INTO THE FLEXCATH IN ATTEMPT TO LOCATE THE TRANSSEPTAL ACCESS AND CROSS BACK INTO THE LA. THIS WAS ALSO TO NO AVAIL. THE DILATOR AND WIRE WERE REMOVED AND A DEFLECTABLE CS CATHETER WAS ADVANCED THROUGH FLEXCATH. THE TRANSSEPTAL ACCESS OPENING WAS QUICKLY AND EASILY CROSSED WITH THE CS CATHETER AND THE FLEXCATH WAS GENTLY ADVANCED BACK INTO THE LA. NO UNEXPECTED CATHETER OR SHEATH JUMPS OCCURRED DURING THIS TRANSITION. THE PHYSICIAN DID NOT MEET RESISTANCE WHEN ADVANCING THE FLEXCATH OVER THE CS CATHETER ACROSS THE INTERATRIAL SEPTUM. THE ARCTIC FRONT CATHETER WAS ADVANCED BACK INTO THE BODY WITH THE ACHIEVE CATHETER. THE PHYSICIAN THEN VERIFIED ABILITY TO PHRENIC PACE AGAIN AND BEGAN TRYING TO ADVANCE THE ACHIEVE CATHETER INTO THE RIPV BRANCHES. HE WAS NOT ABLE TO ADVANCE ACHIEVE FOR SUITABLE SUPPORT. SOME ECG CHANGES WERE NOTED AT THIS TIME AND THE PHYSICIAN CONFIRMED THAT HE HAD SEEN A RIGHT BUNDLE BRANCH BLOCK DEVELOP AT THE TIME THE SEPTUM WAS RE-CROSSED. RIPV ATTEMPTS CONTINUED AND THE PHYSICIAN ASKED FOR A ROSEN WIRE TO UTILIZE INSTEAD OF ACHIEVE. IN PREPARATION FOR THE EXCHANGE, THE SEDATION NURSE CALLED ATTENTION TO A LOW BP (BELOW 50 SBP) BY CUFF PRESSURE. NO ARTERIAL LINE WAS IN PLACE. THE HEART WAS OBSERVED ON FLUORO AND WAS NOT MOVING. CPR WAS INITIATED AND PERICARDIOCENTESIS WAS PERFORMED. FOLLOWING INITIAL OUTPUT IN THE PERICARDIOCENTESIS, THE PHYSICIAN CALLED FOR HEPARIN REVERSAL WITH PROTAMINE. A TOTAL OF MORE THAN 2 LITERS OF BLOOD WAS REMOVED FROM THE PERICARDIAL SPACE. AUTO TRANSFUSION WAS PERFORMED WITH PERICARDIAL BLOOD. THE PATIENT WAS PREPPED FOR SURGERY. AT THE TIME OF SURGERY TRANSFER, THE PATIENT WAS AWAKE AND APPROPRIATELY RESPONSIVE. FOLLOW-UP CONVERSATION WITH THE PHYSICIAN (B)(6) 2011 REVEALED THAT THE PATIENT DID NOT REQUIRE A THORACOTOMY. TEE CONFIRMED THAT THE PERICARDIAL EFFUSION HAS CEASED AFTER SHE WAS TRANSFERRED TO THE OPERATING ROOM. THE PATIENT WAS EXTUBATED (B)(6) 2011 AND RECOVERING WELL. PER THE PHYSICIAN, THE SOURCE OF THE BLEED COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACHIEVE MAPPING CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF MDT ABLATION FRONTIERS MFG 990063-020 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention