BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACQCROSS QX INTERGRATED TRANSSEPTAL DILATOR/NEEDLE

    MDR report key: 16519340 · Received March 9, 2023

    Report

    Report Number
    3012120746-2023-00001
    Event Type
    Death
    Date Received
    March 9, 2023
    Date of Event
    February 21, 2023
    Report Date
    March 9, 2023
    Manufacturer
    ACUTUS MEDICAL, INC.
    Product Code
    DRE
    PMA / PMN Number
    K210685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBMISSION OF THIS REPORT OR RELATED INFORMATION IS NOT NECESSARILY AN ADMISSION THAT OUR EMPLOYEES OR OUR DEVICES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE RIGHT FEMORAL VENOUS WAS ACCESSED WITH 3 SHORT SHEATHS PLACED IN THE GROIN GUIDED WITH ULTRASOUND. THEN THE DUODECA CATHETER WAS INSERTED AS WELL AS THE INTRACARDIAC ECHO WHICH WERE BOTH PLACED THROUGH 2 OF THE 3 SHEATHS IN THE RIGHT GROIN. THE PHYSICIAN PROCEEDED USING AN 11FR SHORT SHEATH TO PRE-DILATE THE GROIN FOR THE ACQCROSS/FLEXCATH COMBO FOR TRANSEPTAL ACCESS. THE 11FR SHORT SHEATH CAME IN AND OUT EASILY WITH NO RESISTANCE MET AT THE GROIN. ADDITIONALLY, THE PHYSICIAN USED A SUPER STIFF 0.032 AMPLATZ GUIDEWIRE FOR TRANSEPTAL USING THE ACQCROSS/FLEXCATH. THE 1ST SUPER STIFF AMPLATZ GUIDEWIRE WAS ADVANCED INTO THE SUPERIOR VENA CAVA (SVC) AND THE ACQCROSS/FLEXCATH WAS THEN ADVANCED OVER THE WIRE AND RESISTANCE WAS FELT. THE PHYSICIAN DID NOT FORCE THE SYSTEM PAST THIS POINT AND VERIFIED WITH FLUORO THAT THE RESISTANCE WAS BEING MET AT THE FEMORAL HEAD. FOLLOWING THIS THE ACQCROSS/FLEXCATH AND SUPER STIFF AMPLATZ GUIDEWIRE WERE REMOVED, AND A KINK WAS SEEN ON THE GUIDEWIRE. A SECOND ATTEMPT TO GET THE ACQCROSS/FLEXCATH OVER THE GUIDEWIRE WAS MADE USING ANOTHER STIFF .032 AMPLATZ WIRE. THE AMPLATZ WIRE WAS PASSED INTO THE SVC AND THE ACQCROSS/FLEXCATH WAS BACKLOADED OVER THE WIRE, BUT RESISTANCE WAS MET AT THE FEMORAL HEAD AGAIN. THE PHYSICIAN REMOVED BOTH AFTER NOT WANTING TO FORCE THE SYSTEM AND DISCOVERED ANOTHER CLEAR KINK IN THE WIRE. THE PHYSICIAN ATTEMPTED TO FIGURE OUT WHY THE RESISTANCE WAS THERE BY ADVANCING A 0.032 J WIRE FROM THE ACQCROSS KIT INTO THE RIGHT FEMORAL VEIN AND THE WIRE BEGAN TO TRACK IN A DIFFERENT DIRECTION, AWAY FROM THE MAIN BODY OF THE FEMORAL VEIN. THE WIRE WOULD NOT ADVANCE INTO THE SVC AS IT HAD BEFORE, AND THE PHYSICIAN SUSPECTED THERE WAS POSSIBLY VENOUS STENOSIS. DR. CRUZ CHOSE TO ABANDON THE TRANSEPTAL ACCESS IN THE RIGHT FEMORAL VEIN AND SWITCHED TOWARDS THE LEFT FEMORAL VEIN FOR ACCESS. BEFORE THE PHYSICIAN HAD SWITCHED TO THE LEFT FEMORAL VEIN FOR ACCESS IT WAS SUGGESTED TO SHOOT A VENOGRAM INTO THE RIGHT FEMORAL VEIN, BUT THE PHYSICIAN DECIDED TO SWITCH TO THE LEFT FEMORAL VEIN DUE TO THE VENOUS ACCESS ISSUES IN THE RIGHT FEMORAL VEIN. ADDITIONALLY, THE PHYSICIAN FELT CONTRAST WAS NOT NEEDED BECAUSE PATIENT DID NOT HAVE HEMATOMA AND GROIN ACCESS WAS OBTAINED WITH ULTRASOUND GUIDANCE THE PHYSICIAN LEFT THE 11FR LONG SHEATH; 11FR SHORT SHEATH AND 7FR SHORT SHEATH IN THE RIGHT FEMORAL VEIN. HE GAINED LEFT FEMORAL ACCESS WITH A 10FR LONG SHEATH WHICH WAS SWITCHED OUT FOR A 3RD SUPER STIFF .032 AMPLATZ WIRE AND THE ACQCROSS/FLEXCATH FOR TRANSEPTAL. GROIN RESISTANCE WAS MET, AND THE WIRE KINKED SO THE PHYSICIAN REQUESTED A 16FR LONG SHEATH AND A FINAL 4TH SUPER STIFF AMPLATZ 0.032 WIRE. THE ACQCROSS/FLEXCATH TRACKED NICELY OVER THIS 4TH WIRE WHERE TRANSEPTAL ACCESS WAS GAINED WITHOUT COMPLICATION, AND IT EASILY ACCESSED THE HEART AND SVC. PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THIS ENTIRE PROCESS AND THE PHYSICIAN CONFIRMED THERE WAS NO EFFUSION MULTIPLE TIMES THROUGHOUT THE CASE. FURTHERMORE, THE PHYSICIAN WAS ABLE TO COMPLETE THE CRYO PORTION OF THE PROCEDURE, WHERE HE ISOLATED ALL 4 VEINS, ABLATED THE LEFT ATRIAL POSTERIOR WALL, AND ABLATED THE LEFT ATRIAL ROOF. THE PATIENT NEVER SHOWED SIGNS OF DECOMPENSATION. THE BALLOON AND ACHIEVE MAPPING CATHETER WERE REMOVED AND A CRYO POST MAP WAS BEING PERFORMED AS WELL AS A VERY DETAIL MAP OF THE LEFT ATRIAL WAS COLLECTED WITH THE ABBOTT HD GRID. WHILE THE PHYSICIAN WAS PREPARING THE TACTICATH ABBOTT OPEN IRRIGATED RF ABLATION CATHETER FOR LEFT ATRIAL FLUTTER ABLATION, TO ABLATE THE LEFT ATRIAL FLUTTER, THE ANESTHESIA DOCTOR NOTICED A DROP IN THE PATIENT'S BLOOD PRESSURE. THE PRESSURE CONTINUED TO DROP AND THE PHYSICIAN BEGAN PREPARATION TO OBTAIN FEMORAL ARTERIAL ACCESS. WHILE THE ULTRASOUND WAS BEING PREPARED FOR THIS, THE PATIENT WENT INTO A VENTRICULAR FIBRILLATION ARREST AND ENTERED CARDIAC ARREST. CPR WAS PERFORMED UNTIL HEART RATE AND BLOOD PRESSURE RESOLVED AFTER SEVERAL MINUTES. DURING CPR, MULTIPLE BLOOD TESTS WERE DONE AND BLOOD WAS GIVEN TO THE PATIENT. A HEART CATHETERIZATION WAS ALSO PERFORMED BY AN INTERVENTIONAL CARDIOLOGIST. THE CARDIOLOGIST STATED THE CORONARIES WERE NOT IN A CONDITION THAT WOULD HAVE CAUSED THE VFIB ARREST AND THERE WAS ALSO DISCUSSION ON WHETHER THE PATIENT NEEDED SUPPORT FOR HEART CONTRACTILITY. THE ANESTHESIA DOCTOR AND CARDIAC INTERVENTIONALISTS AGREED THAT AN IMPELLA WOULD HELP THE PATIENT'S OUTCOME AND RECOVERY. SO, AN IMPELLA WAS PLACED IN THE RIGHT FEMORAL ARTERY. AFTER ALL THIS, THE PATIENT WAS HEMODYNAMICALLY STABLE BUT PROGRESSING BACK TO LOW BLOOD PRESSURE AND HEART RATE. THE ANESTHESIA AND CARDIOLOGIST DISCUSSED IF THERE WAS POSSIBILITY THAT THE PATIENT WAS BLEEDING FROM SOMEWHERE DUE TO LOW VOLUME AND PRESSURE IN LEFT VENTRICULAR" FROM IMPELLA. THE PHYSICIAN MENTIONED THE ISSUES WITH RIGHT FEMORAL VENOUS ACCESS AND THE INTERVENTIONAL CARDIOLOGIST PERFORMED A RIGHT FEMORAL VENOGRAM TO DETERMINE IF THE PATIENT HAD A VENOUS DISSECTION. A DISSECTION WAS CONFIRMED NEAR THE FEMORAL HEAD OF THE RIGHT FEMORAL VEIN. THE AREA WAS BALLOONED TO HELP STABILIZE THE BLEED UNTIL AN INTERVENTIONAL RADIOLOGIST COULD COME IN TO STENT THE VESSEL. A STENT WAS PLACED AND THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT FOR CONTINUED CARE. IT WAS REPORTED THAT ON (B)(6) THE PATIENT PASSED AWAY DUE TO COMPLICATION FROM THE PROCEDURE. POST PROCEDURE THE INTERVENTIONAL CARDIOLOGIST STATED THAT THE FEMORAL ARTERIES WERE EXTREMELY SMALL WHICH WOULD MAKE IT DIFFICULT TO PLACE AN IMPELLA IN EITHER LEG. ADDITIONALLY, IT WAS ALSO STATED THAT THE CORONARY ARTERIES APPEARED STENOSED DURING THE HEART CATHETERIZATION BUT WAS UNSURE IF THE APPEARANCE WAS BECAUSE OF ALL THE MEDICATIONS GIVEN DURING CPR. IT WAS SPECIFIED THAT IT WAS NOT BELIEVED THAT THE CORONARY ARTERIES LOOKED TO BE THE CAUSE OF THE VENTRICULAR FIBRILLATION ARREST AT THAT POINT AND TIME. THE AVAILABLE INFORMATION DOES NOT INDICATE A CAUSAL RELATIONSHIP BETWEEN THE USE OF THE ACQCROSS DEVICE AND THE REPORTED ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218143 ACQCROSS QX INTERGRATED TRANSSEPTAL DILATOR/NEEDLE TRANSSEPTAL DILATOR/NEEDLE DRE ACUTUS MEDICAL, INC. 900304-001 103703

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Death .032 AMPLATZ GUIDEWIRE| 10FR LONG SHEATH| 11 FR SHORT SHEATH| 11FR LONG SHEATH| 16FR LONG SHEATH| 7FR SHORT SHEATH| ABBOTT HD GRID| ACHIEVE MAPPING CATHETER| BALLOON CATHETER| DUODECA CATHETER| FLEXCATH| IMPELLA| INTRACARDIAC ECHO| TACTICATH ABBOTT OPEN IRRIGATED RF ABLATION CATHET