BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOPSY FORCEPS

    MDR report key: 8488899 · Received April 5, 2019

    Report

    Report Number
    1016427-2019-02684
    Event Type
    Injury
    Date Received
    April 5, 2019
    Date of Event
    December 9, 2014
    Report Date
    April 5, 2019
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DWZ
    PMA / PMN Number
    K933235
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE REPORT ALSO REPRESENTS NOTIFICATION OF 1 EVENT FOR VENTRICULAR FIBRILLATION. PLEASE NOTE THAT PATIENT SPECIFIC DETAILS (DEMOGRAPHICS, MEDICAL HISTORY AND REASON FOR INTERVENTION) ARE NOT AVAILABLE. THE DEVICE IS THE BIOPSY FORCEPS BUT THE CATALOG AND LOT NUMBERS ARE NOT AVAILABLE. THE CITATION IS AS FOLLOWS: "AWAD - ENDOMYOCARDIAL BIOPSY TECHNIQUE FOR ORTHOTOPIC HEART TRANSPLANTATION AND CARDIAC STEM-CELL HARVESTING". AS REPORTED IN THE LITERATURE ARTICLE BY AWAD, M., RUZZA, A., SOLIMAN, C., PINZÁS, J., MARBAN, E., TRENTO, A., & CZER, L. (2014), "ENDOMYOCARDIAL BIOPSY TECHNIQUE FOR ORTHOTOPIC HEART TRANSPLANTATION AND CARDIAC STEM-CELL HARVESTING." TRANSPLANTATION PROCEEDINGS, 46 (10), 3580-3584. DOI: 10.1016/J.TRANSPROCEED.2014.05.084; A BIOPSY PROCEDURE WAS PERFORMED AFTER ORTHOTOPIC HEART TRANSPLANTATION (OHT) WITH THE BICAVAL TECHNIQUE USING CORDIS BIOPTOME, AND THERE WAS ONE OCCURRENCE OF VENTRICULAR FIBRILLATION REQUIRING CARDIOVERSION, AND NO OCCURRENCE OF CARDIAC TAMPONADE DURING THE PROCEDURE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS THE STERILE LOT NUMBER WAS NOT PROVIDED. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS AND WITHOUT FILMS OF THE EVENT, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. PROCEDURES REQUIRING BIOPSY FORCEPS SHOULD NOT BE ATTEMPTED BY PHYSICIANS UNFAMILIAR WITH THE POSSIBLE COMPLICATIONS. COMPLICATIONS MAY OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE. POSSIBLE COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: HEMATOMA AT THE PUNCTURE SITE; INFECTION; PERFORATION OF THE VESSEL WALL OR THE MYOCARDIUM; VESSEL TRAUMA; EMBOLISM; DEATH. GIVEN THE LIMITED INFORMATION AVAILABLE FOR REVIEW AT THIS TIME, THERE IS NOTHING TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE ARTICLE BY AWAD, M., RUZZA, A., SOLIMAN, C., PINZÁS, J., MARBAN, E., TRENTO, A., & CZER, L. (2014), "ENDOMYOCARDIAL BIOPSY TECHNIQUE FOR ORTHOTOPIC HEART TRANSPLANTATION AND CARDIAC STEM-CELL HARVESTING." TRANSPLANTATION PROCEEDINGS, 46 (10), 3580-3584. DOI: 10.1016/J.TRANSPROCEED.2014.05.084; A BIOPSY PROCEDURE WAS PERFORMED AFTER ORTHOTOPIC HEART TRANSPLANTATION (OHT) WITH THE BICAVAL TECHNIQUE USING CORDIS BIOPTOME, AND THERE WAS ONE OCCURRENCE OF VENTRICULAR FIBRILLATION REQUIRING CARDIOVERSION, AND NO OCCURRENCE OF CARDIAC TAMPONADE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281226 UNKNOWN BIOPSY FORCEPS DEVICE, BIOPSY, ENDOMYOCARDIAL DWZ CORDIS CORPORATION UNK-BIOPSYFORCEPS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1