BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE

    MDR report key: 14945084 · Received July 7, 2022

    Report

    Report Number
    2029046-2022-01532
    Event Type
    Injury
    Date Received
    July 7, 2022
    Date of Event
    October 1, 2021
    Report Date
    July 7, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF. NO: (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: JIANG LI XIAOMEI, ZHANG YI LI MEITING , LIU HAIJU LI HAO, ZHOU YIMING. RADIOFREQUENCY ABLATION OF 328 CASES OF PEDIATRIC IDIOPATHIC ARRHYTHMIA IN RECENT 5 YEARS IN A SINGLE CENTER . CHINESE JOURNAL OF PRACTICAL PEDIATRICS, OCTOBER 2021, VOL. 36, NO. 19, CHINJAPPLCLINPEDIATR, OCTOBER2021, VOL. 36, NO. 19. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: JIANG LI XIAOMEI, ZHANG YI LI MEITING , LIU HAIJU LI HAO, ZHOU YIMING. RADIOFREQUENCY ABLATION OF 328 CASES OF PEDIATRIC IDIOPATHIC ARRHYTHMIA IN RECENT 5 YEARS IN A SINGLE CENTER . CHINESE JOURNAL OF PRACTICAL PEDIATRICS, OCTOBER 2021, VOL. 36, NO. 19, CHINJAPPLCLINPEDIATR, OCTOBER2021, VOL. 36, NO. 19. OBJECTIVE/METHODS/STUDY DATA: OBJECTIVE TO INVESTIGATE THE ELECTROPHYSIOLOGICAL CHARACTERISTICS AND RADIOFREQUENCY ABLATION EFFECT OF IDIOPATHIC ARRHYTHMIA (VAS) IN CHILDREN. METHODS FROM JANUARY 2014 TO DECEMBER 2019, 328 CHILDREN WITH IDIOPATHIC VAS UNDERWENT RADIOFREQUENCY ABLATION IN THE FIRST AFFILIATED HOSPITAL OF TSINGHUA UNIVERSITY, INCLUDING 205 MALES AND 123 FEMALES; AGE (7. 8 ± 3. 9) YEARS; BODY MASS (32. 8 ± 17.7) KG. THE ELECTROPHYSIOLOGICAL CHARACTERISTICS AND RADIOFREQUENCY ABLATION RESULTS OF VAS AT DIFFERENT ORIGIN SITES IN CHILDREN WERE ANALYZED. AS A RESULT, THE AGE OF FIRST ONSET OF THE 328 CHILDREN WAS (5. 4 ± 4. 1), FREQUENT EXTRA SYSTOLES ACCOUNTED FOR 57. 6%, NON-SUSTAINED TACHYCARDIA ACCOUNTED FOR 28. 7%, PERSISTENT TACHYCARDIA ACCOUNTED FOR 13. 7%; 38 PATIENTS WITH TACHYCARDIA-INDUCED CARDIOMYOPATHY (11. 6%, 38/328). OF THE 328 CHILDREN, EXCEPT FOR 13 WHO FAILED TO INDUCE VAS DURING SURGERY, 315 MAPPING CONFIRMED THAT VAS ORIGINATED FROM THE OUTFLOW TRACT IN 152 CASES (152/328 CASES, 46. 4%), INCLUDING THE RIGHT VENTRICULAR OUTFLOW TRACT SEPTAL SITE 46. 1%, LEFT CORONARY SINUS 27. 6%, RIGHT CORONARY SINUS 18. 4%, RIGHT VENTRICULAR OUTFLOW TRACT FREE WALL 7. 9%; TRICUSPID ANNULUS IN 55 PATIENTS (55/328 PATIENTS, 16. 5%); LEFT POSTERIOR BRANCH IN 54 PATIENTS (54/328 PATIENTS, 17. 4%); 39 PATIENTS (39/328 PATIENTS, 11. 9%); 5 CASES WERE MULTIPLE (5/328 CASES, 1. 5%); LEFT ANTERIOR BRANCH IN 3 CASES (3/328 CASES, 0. 9%); OTHER 7 (7/328, 2. 1%). RADIOFREQUENCY ABLATION WAS PERFORMED IN 307 PATIENTS (307/328 PATIENTS, 93. 6%), IMMEDIATE SUCCESS IN 271 (271/307, 88. 3%), EFFECTIVE IN 14 (14/307, 4. 6%), FAILURE IN 22 (22/307, 7. 2%).CONCLUSION THE RIGHT VENTRICULAR OUTFLOW TRACT SEPTUM IS THE MOST COMMON SITE OF IDIOPATHIC VAS ORIGINATING FROM THE OUTFLOW TRACT IN CHILDREN; THE ABLATION EFFECT OF OUTFLOW TRACT AND TRICUSPID ANNULUS ORIGIN IS GOOD, AND THE RECURRENCE RATE OF LEFT VENTRICULAR BRANCH TYPE AND LEFT POSTERIOR PAPILLARY MUSCLE ORIGIN IS RELATIVELY HIGH; RADIOFREQUENCY ABLATION OF IDIOPATHIC VAS IN INFANTS IS RELATIVELY SAFE AND EFFECTIVE, BUT THE SURGICAL INDICATIONS SHOULD BE STRICTLY GRASPED AND OPERATED BY EXPERIENCED PEDIATRIC ELECTROPHYSIOLOGISTS; THREE-DIMENSIONAL MAPPING GUIDED RADIOFREQUENCY ABLATION CAN CONTROL THE RADIATION DOSE IN A VERY LOW SAFETY RANGE. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: 8FR MULTIFUNCTIONAL SHEATH (JOHNSON & JOHNSON, USA). WILL BE CODED AS UNK_PREFACE SHEATH FOR REPORTABILITY PURPOSES. OTHER BIOSENSE WEBSTER CONCOMITANT DEVICES THAT WERE ALSO USED IN THIS STUDY: -CARTO (JOHNSON & JOHNSON, USA). 7FR COLD SALINE PERFUSION ABLATION CATHETER (JOHNSON & JOHNSON, USA). WILL BE CONSIDERED CONCOMITANT AS THEY NOTE COMPLICATIONS WERE VASCULAR RELATED THEREFORE LIKELY RELATED TO THE SHEATH. NON-BIOSENSE WEBSTER CONCOMITANT DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: INTRAOPERATIVE RELATED VASCULAR COMPLICATIONS OCCURRED IN 4 CASES (4/328 CASES); AMONG THEM, 3 CASES WERE RIGHT FEMORAL ARTERY STENOSIS ( THIS WILL BE CODED AS VASCULAR PSEUDOANEURYSM) WITH THROMBOEMBOLISM ( THIS WILL BE CODED AS THROMBOSIS). 1 CASE OF PSEUDOANEURYSM WAS CURED BY SURGICAL TREATMENT. THERE WAS NO FURTHER MENTION OF INTERVENTIONS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967649 PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L 7FR COLD SALINE PERFUSION ABLATION CATHETER (J&J)| CARTO (JOHNSON & JOHNSON, USA)