BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXABILITY ABLATION CATHETER-UNKNOWN

    MDR report key: 23135364 · Received September 24, 2025

    Report

    Report Number
    3008452825-2025-00478
    Event Type
    Injury
    Date Received
    September 24, 2025
    Report Date
    September 24, 2025
    Manufacturer
    ABBOTT MEDICAL, COSTA RICA LTDA
    Product Code
    OAD
    PMA / PMN Number
    P110016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MODEL/LOT NUMBER INFORMATION WAS NOT ABLE TO BE OBTAINED FOR THIS DEVICE. THEREFORE, FULL UDI INFORMATION(D4) AND 510K(G3) ARE NOT AVAILABLE. AN EVENT OF AN ESOPHAGEAL BURN, TIA AND STEAM POP WERE REPORTED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF EUROPEAN SOCIETY OF CARDIOLOGY IN AND ARTICLE TITLED "VERY HIGH-POWER SHORT-DURATION USING 70W AND A FLEXIBLE TIP ABLATION CATHETER FOR PULMONARY VEIN ISOLATION: THE POWER PULSE RANDOMIZED CONTROLLED TRIAL", MIRUNA A. POPA, EUROPACE (2025) 27, EUAF105 HTTPS://DOI.ORG/10.1093/EUROPACE/EUAF105. A TOTAL OF N = 200 PATIENTS WITH PAROXYSMAL AF WERE RANDOMLY ASSIGNED 1:1 TO RECEIVE PULMONARY VEIN ISOLATION (PVI) USING VHPSD (70 W/5¿7 S) OR STANDARD (30¿40W, 20¿40 S) ABLATION WITH A FLEXIBLE, ENHANCED-IRRIGATION TIP CATHETER. PRIMARY ENDPOINT WAS THE NUMBER OF RECONNECTED PULMONARY VEINS (RPV) AFTER ADENOSINE TESTING. SECONDARY ENDPOINTS INCLUDED FIRSTPASS ISOLATION (FPI), SILENT CEREBRAL LESIONS (SCLS) AND RHYTHM OUTCOMES ON 12-MONTH FOLLOW-UP. MEAN NUMBER OF RPVS WAS 0.6 ± 0.8 VS. 0.8 ± 0.9 (P = 0.145) WITH VHPSD-70W VS. STANDARD ABLATION. BILATERAL FPI WAS 42.7% VS. 30.2% (P = 0.072), WHILE FPI OF LEFT PVS WAS HIGHER WITH VHPSD-70W (63.5% VS. 49.0%, P = 0.042). PROCEDURE (107.7 ± 34.2 VS. 131.3 ± 42.2 MIN) AND RADIOFREQUENCY (15.1 ± 6.7 VS. 41.8 ± 18.3 MIN) DURATION WERE SIGNIFICANTLY LOWER WITH VHPSD-70W (P < 0.001). SILENT CEREBRAL LESIONS OCCURRED IN 1/25 (4.0%) VS. 3/22 (13.6%, P = 0.328). ON 12-MONTH FOLLOW-UP, FREEDOM FROM ANY ATRIAL ARRHYTHMIA (76.0% VS. 66.7%, P = 0.171) WAS SIMILAR, WHILE VHPSD-70W SHOWED A LOWER INCIDENCE OF ATRIAL TACHYCARDIA (AT) RECURRENCE (1.0% VS. 10.4%, P = 0.005). "SAFETY ENDPOINTS ARE LISTED IN TABLE 3. NO STATISTICALLY SIGNIFICANT DIFFERENCES IN THE RATE OF STEAM POPS (5/96 [5.2%] VS. 0/96 [0.0%], P = 0.059), SCLS (1/25 [4.0%] VS. 3/22 [13.6%], P = 0.328) AND TRANSIENT ISCHAEMIC ATTACKS (1/96 [1.0%] VS. 0/96 [0.0%], P = 1.000) WERE OBSERVED BETWEEN VHPSD-70W AND STANDARD APPROACH. NO PATIENT IN THE VHPSD-70W GROUP PRESENTED ANY OESOPHAGEAL SYMPTOMS, WHILE TWO PATIENTS IN THE STANDARD GROUP REQUIRED ENDOSCOPY DUE TO SYMPTOMS OCCURRING AFTER 1 AND 4 DAYS, RESPECTIVELY. IN THE LATTER PATIENT, AN OESOPHAGEAL THERMAL LESION WAS CONFIRMED, WHICH RESOLVED AFTER TREATMENT WITH PROTON PUMP INHIBITORS. NO STROKE, CARDIAC ARREST OR DEATH OCCURRED IN ANY OF THE GROUPS. EMERGENT RE-ADMISSION DUE TO RECURRENCE OF ANY ATRIAL ARRHYTHMIA OCCURRED IN 2/96 (2.1%) VS. 8/96 (8.3%) AFTER VHPSD-70W VS. STANDARD ABLATION (P = 0.051)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1641994 FLEXABILITY ABLATION CATHETER-UNKNOWN catheter, percutaneous, cardiac ablation, for treatment of atrial flutter OAD ABBOTT MEDICAL, COSTA RICA LTDA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention