BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM

    MDR report key: 12393806 · Received August 31, 2021

    Report

    Report Number
    2029046-2021-01417
    Event Type
    Injury
    Date Received
    August 31, 2021
    Date of Event
    August 3, 2021
    Report Date
    August 3, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    PMA / PMN Number
    K170997
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ON 7-SEP-2021, BIOSENSE WEBSTER INC. (BWI) RECEIVED ADDITIONAL INFORMATION INDICATING A 8FR SL1 SHEATH, A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM AND AN 8FR SHORT SHEATH WERE USED DURING THIS PROCEDURE. THESE 8FR SL1 SHEATH AND 8FR SHORT SHEATH HAS BEEN ADDED TO THE CONCOMITANT PRODUCTS SECTION. BASED ON THE NEW INFORMATION, THE FOLLOWING FIELDS HAVE BEEN UPDATED ACCORDINLY: D1. BRAND NAME HAS BEEN UPDATED FROM ¿PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE¿ TO CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM. D4. CATALOG HAS BEEN UPDATED FROM ¿UNK_PREFACE SHEATH¿ TO ¿D138502¿, D4. UNIQUE IDENTIFIER( UDI) WAS UPDATED FROM ¿BLANK¿ TO ¿(B)(4), G1. MANUFACTURING SITE NAME WAS UPDATED FROM ¿BIOSENSE WEBSTER INC (JUAREZ)¿, TO ¿BIOSENSE WEBSTER INC (IRVINE)¿, G1. MANUFACTURER SITE ADDR. STREET LINE 1 WAS UPDATED FROM ¿CIRCUITO INTERIOR NORTE¿ TO ¿33 TECHNOLOGY DRIVE¿, G1. MANUFACTURER SITE ADDR. STREET LINE 2 REMOVE ¿1820PARQUE INDUSTRIAL SALVACAR¿, G.1 MANUFACTURER SITE CITY WAS UPDATED FROM ¿JUAREZ¿ TO ¿IRVINE¿, G1. MANUFACTURER SITE STATE CODE WAS UPDATED FROM ¿BLANK¿ TO ¿CA¿, G1. MANUFACTURER SITE ZIP CODE WAS UPDATED FROM ¿BLANK¿ TO ¿92618¿, G1. MANUFACTURER SITE COUNTRY CODE WAS UPDATED FROM ¿MEX¿ TO ¿USA¿, G1. 1. MANUFACTURER SITE POSTAL CODE UPDATED FROM ¿32599¿ TO ¿BLANK¿, G1. MANUFACTURER SITE EMAIL UPDATED FROM (B)(4) TO ¿BLANK¿, G1. MANUFACTURER SITE PHONE WAS UPDATED FROM (B)(4) TO ¿BLANK¿, G 4. PMA/ 510(K) UPDATED FROM ¿BLANK¿ TO ¿K170997¿. IN ADDITION, IT WAS ALSO REPORTED THAT THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM IS NOT AVAILABLE FOR RETURN, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. BIOSENSE WEBSTER INC.'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS: IMPORTER REPORT NUMBER # 2029046-2021-50006 PRODUCT CODE M490008 (SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US)).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE AND A SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US) AND THE PATIENT SUFFERED AIR EMBOLISM AND ST SEGMENT ELEVATION REQUIRING INTERVENTIONAL CARDIOLOGY INTERVENTION. IT WAS REPORTED THAT DURING THE AFIB CASE, DURING USE OF BIOSENSE WEBSTER PRODUCTS, THE NURSE STAFF WENT TO FAST FLUSH ON THE SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US) AND SHE DID NOT NOTICE THAT THERE WAS AIR IN THE BAG AND FLUSHED INTO THE PATIENT. THE PATIENT HAD ST ELEVATION. THEY PUT ON 100 PERCENT OXYGEN AND INTERVENTIONAL CARDIOLOGY WAS ABLE TO GET THE AIR OUT THE RIGHT CORONARY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS USER ERROR. PATIENT OUTCOME FROM THE ADVERSE EVENT IS REPORTED TO BE IMPROVED. THE PATIENT DID NOT HAVE AN EXTENDED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293925 CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R SMARTABLATE GENERATOR KIT-US| SMARTABLATE PUMP KIT-US| THMCL SMTCH SF BID, TC, D-F| UNSPECIFIED 8FR SHORT SHEATH| UNSPECIFIED 8FR SL1 SHEATH| SMARTABLATE GENERATOR KIT-US| SMARTABLATE PUMP KIT-US| THMCL SMTCH SF BID, TC, D-F