BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH UNIDIRECTIONAL

    MDR report key: 12372453 · Received August 26, 2021

    Report

    Report Number
    2029046-2021-01395
    Event Type
    Injury
    Date Received
    August 26, 2021
    Date of Event
    January 16, 2021
    Report Date
    August 3, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF. NO: (B)(4). NOTIFICATION FOR (B)(4) SUBMITTED ON 08/26/2021 THAT THE CORRECT DATE FOR "G3. DATE RECEIVED BY MANUFACTURER" IS ALSO 08/03/2021 IN ADDITION TO B4. DATE OF THIS REPORT OF 08/03/2021. B4. DATE OF THIS REPORT 08/03/2021.

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REF. NO: (B)(4). INVESTIGATION SUMMARY : SINCE THE PRODUCT HAS NOT BEEN RETURNED, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. AS A RESULT, WE ARE CLOSING THIS INVESTIGATION. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE LITERATURE ARTICLE TITLED, "MINIMIZING RADIATION EXPOSURE IN CATHETER ABLATION OF VENTRICULAR ARRHYTHMIAS" WRITTEN BY MATEVZ JAN, DAVID ZIZEK, TINE PROLIC KALINSEK, DIMITRIJ KUHELJ, PRIMOZ TRUNK, TADEJA KOLAR, JUS KSELA, MARTIN RAUBER AND MEHMET YAZICI PUBLISHED BY BMC CARDIOVASCULAR DISORDERS 2021 JUN 16;21(1):306. DOI: 10.1186/S12872-021-02120-4. PMID: 34134637; PMCID: PMC8210369. WAS REVIEWED. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNI-DIRECTIONAL IRRIGATED TIP THERMOCOOL SMARTTOUCH AND SMARTTOUCH SF ABLATION CATHETERS IN GROUP 1; PENTARAY MULTIPOLAR CATHETER FOR HIGH-DENSITY MAPPING IN PATIENTS WITH SHD (STRUCTURAL HEART DISEASE) IN GROUP 2. OTHER BIOSENSE PRODUCTS UTILIZED IN STUDY: CARTO 3D EAM SYSTEM (MAPPING), ACUSON ACUNAV (INTRA-CARDIAC ECHOCARDIOGRAPHY), NON-BIOSENSE PRODUCTS UTILIZED IN STUDY: NAVX PRECISION (ABBOTT MAPPING), AGILIS LONG SHEATH 9ABBOTT), FLEXIBILITY ABLATION CATHETERS (ABBOTT). EXACT QUANTITIES OF INVOLVED PRODUCTS CANNOT BE ACCURATELY DETERMINED AS THE ARTICLE DOES NOT SPECIFY WHICH SPECIFIC ABLATION CATHETERS ARE ASSOCIATED WITH EACH ADVERSE EVENT. THE FOLLOWING ADVERSE EVENT(S) WERE REPORTED IN THIS PUBLICATION IN TABLE 3 CAPTURED UNDER PROCEDURAL COMPLICATIONS: GROUP ONE: ONE PATIENT HAD PERFORATION OF RV (TREATED SURGICALLY). GROUP ONE: ONE PATIENT HAD LATE PERICARDIAL TAMPONADE (TREATED WITH PERCUTANEOUS DRAINAGE). GROUP TWO: ONE PATIENT HAD PSEUDO-ANEURYSM OF LEFT FEMORAL ARTERY (TREATED SURGICALLY). OBJECTIVE: AIM WAS TO ANALYZE PROCEDURAL OUTCOMES WITH FLUOROSCOPY MINIMIZING APPROACH FOR TREATMENT OF VAS IN PATIENTS WITH STRUCTURALLY NORMAL HEARTS (SNH) IN GROUP 1 AND STRUCTURAL HEART DISEASE (SHD) IN GROUP 2. METHODS: FIFTY-TWO (AGE 53.4±17.8 YEARS, 38 MALE, 14 FEMALE) CONSECUTIVE PATIENTS WHO UNDERWENT CA OF VAS IN THE INSTITUTION BETWEEN MAY 2018 AND DECEMBER 2019 WERE INCLUDED. PROCEDURES WERE PERFORMED PRIMARILY WITH THE AID OF THE THREE-DIMENSIONAL ELECTRO-ANATOMICAL MAPPING SYSTEM AND INTRA-CARDIAC ECHOCARDIOGRAPHY. FLUOROSCOPY WAS CONSIDERED ONLY IN LEFT VENTRICULAR (LV) SUMMIT MAPPING FOR CORONARY ANGIOGRAPHY AND WHEN EPICARDIAL APPROACH WAS PLANNED. ACUTE AND LONG-TERM PROCEDURAL OUTCOMES WERE ANALYZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271862 UNK_SMART TOUCH UNIDIRECTIONAL SIMILAR DEVICE D133601, PMA # P030031/S053 OAD BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention AGILIS LONG SHEATH| FLEXABILITY ABLATION CATHETERS| NAVX PRECISION