BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAFESEPT TRANSSEPTAL GUIDEWIRE

    MDR report key: 25255208 · Received May 22, 2026

    Report

    Report Number
    3013986346-2026-00001
    Event Type
    Death
    Date Received
    May 22, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 21, 2026
    Manufacturer
    PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
    Product Code
    DRC
    UDI-DI
    00858769006104
    PMA / PMN Number
    K170671
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING A VT PROCEDURE, THE AORTA WAS PERFORATED WHICH REQUIRED SURGERY AND THE PATIENT SUBSEQUENTLY DIED. THE PATIENT WAS HIGH RISK AND HAD MULTIPLE MORBIDITIES. BASED ON COMMUNICATION WITH (B)(4) THROUGH OUR DISTRIBUTOR IN GERMANY, (B)(4), IT WAS COMMUNICATED THAT THE TRANSSEPTAL PUNCTURE ATTEMPT WITH THE SAFESEPT WIRE DID NOT CORRELATE WITH THE OCCURRENCE OF TAMPONADE ON THIS CASE. THE SAFESEPT WAS USED AS A SAFETY TECHNIQUE FOR TRANSSEPTAL ACCESS AND IS THE ROUTINE APPROACH FOR FLUOROSCOPY GUIDED TSP. INADVERTENT AORTIC ROOT PUNCTURE BY SAFESEPT WAS NOT FOLLOWED BY EXCHANGING OR PROTRUDING LARGER SHEATHS OR NEEDLES AND WIRE WAS RETRACTED. NO ACUTE CONSEQUENCE OCCURRED DURING THE WAITING PERIOD AFTER FAILED TSP WITH THE SAFESEPT. IT IS POSSIBLE THAT MIS-PUNCTURE OCCURRED DUE TO MISINTERPRETATION OF FLUOROSCOPIC IMAGES. A REVIEW OF LOT001727 WAS CONDUCTED. ALL PROCEDURES WERE COMPLETED WITH NO DEVIATIONS NOTED, AND ALL PROCEDURES WERE COMPLETED SATISFACTORILY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A VT PROCEDURE, THE AORTA WAS PERFORATED BY THE NON-ABBOTT WIRE (SAFESEPT) WHICH REQUIRED SURGERY AND THE PATIENT SUBSEQUENTLY DIED. THE PATIENT WAS HIGH RISK AND HAD MULTIPLE MORBIDITIES. DURING TRANSSEPTAL PUNCTURE WITH THE AGILIS SHEATH, BRK NEEDLE, AND A NON-ABBOTT (SAFESEPT WIRE), THE PHYSICIAN PUNCTURED THE AORTA WITH THE SAFESEPT. HE IMMEDIATELY PULLED BACK THE WIRE. HE TRIED AGAIN AND THIS TIME THE PUNCTURE WAS RIGHT, BUT HE COULD NOT PUSH THE AGILIS DILATOR OVER THE HOLE. HE THEN TRIED A 3RD TIME AND WAS ABLE TO DO A SUCCESSFUL TRANSSEPTAL PUNCTURE. AFTER ADVANCING THE ADVISOR HD GRID CATHETER THROUGH THE AGILIS SHEATH IN THE LV HE ASKED THE ATTENDING CO PHYSICIAN TO DO A CARDIAC ULTRASOUND. THEREBY A PERICARDIAL EFFUSION WAS DIAGNOSED. BLOOD PRESSURE DROPPED TO 60/30. A PERICARDIOCENTESIS WAS PERFORMED AND THE REANIMATION TEAM AND CHIEF PHYSICIANS AND HEART SURGERY WERE CONTACTED. THE CHIEF OF EP TOOK OVER AND WAS ABLE TO PULL OUT LARGE AMOUNTS OF BLOOD. BLOOD PRESSURE STABILIZED TO 120/80. THE PHYSICIAN COULD NOT NO LONGER REMOVE ANY MORE BLOOD. PROTAMIN WAS GIVEN, HOWEVER THE PERICARDIUM WAS FILLING AGAIN WITH BLOOD, WHICH CLOTTED AND WAS NOT ABLE TO BE PULLED OUT. BLOOD PRESSURE DROPPED TO NEAR ZERO. CPR WAS THEN STARTED. CARDIAC SURGEONS OPENED THE THORAX AND PERFORMED EMERGENCY SURGERY TO FIND AN UNRESPONSIVE HEART WHICH HAD A PERFORATED AORTA. THEY WERE ABLE TO RETRIEVE A BIG AMOUNT OF COAGULATED BLOOD SURROUNDING THE HEART. PATIENT WAS THEN DECLARED DEAD. PATIENT IS NOW IN PATHOLOGY FOR OBDUCTION. THE PHYSICIAN CONFIRMED THAT THE NON-ABBOTT DEVICE (SAFESEPT WIRE) PUNCTURED THE AORTA AND THE PUNCTURED AORTA WAS THE CAUSE OF THE PATIENT'S DEATH. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576662 SAFESEPT TRANSSEPTAL GUIDEWIRE TRANSSEPTAL GUIDEWIRE DRC PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC SS-135 001727 00858769006104

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death