BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOPSY FORCEPS

    MDR report key: 14197344 · Received April 25, 2022

    Report

    Report Number
    1016427-2022-05400
    Event Type
    Injury
    Date Received
    April 25, 2022
    Date of Event
    January 1, 1980
    Report Date
    April 26, 2022
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. WITHOUT A LOT NUMBER TO CONDUCT A DEVICE HISTORY RECORD (DHR) REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 0

    AS PER, BIOPSY FORCEPS ACTIVE POST-MARKET SURVEILLANCE SURVEY REPORTED THEY HAVE EXPERIENCED PERICARDIAL TAMPONADE. ALSO, COMMENTING ¿PERICARDIAL EFFUSION FOLLOWED BY TAMPONADE DUE TO THE PATIENT BEING ON ANTICOAGULANTS.¿ THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO LOT NUMBER WAS PROVIDED THEREFORE A PRODUCT HISTORY RECORD (PHR) REVIEW COULD NOT BE GENERATED. GIVEN THE LIMITED INFORMATION PROVIDED, THE REPORTED EVENT ¿CARDIAC TAMPONADE¿ AND ¿PERICARDIAL EFFUSION¿ COULD NOT BE CONFIRMED, AND THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), 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 AND ARE LISTED ON THE IFU. 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, AND DEATH. CARDIAC TAMPONADE CAN RESULT FROM A PERICARDIAL EFFUSION AND IS A SERIOUS MEDICAL CONDITION IN WHICH BLOOD OR FLUIDS FILL THE SPACE BETWEEN THE SAC THAT ENCASES THE HEART AND THE HEART MUSCLE. THIS PLACES EXTREME PRESSURE ON YOUR HEART. THE PRESSURE PREVENTS THE HEART'S VENTRICLES FROM EXPANDING FULLY AND KEEPS YOUR HEART FROM FUNCTIONING PROPERLY. THIS REQUIRES URGENT DRAINAGE OF THE FLUID, AS WAS DONE IN THIS CASE (PERICARDIOCENTESIS). VESSEL CHARACTERISTICS AND PROCEDURAL/HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. MOREOVER, IT WAS REPORTED THAT THESE EVENTS FOLLOWED DUE TO THE PATIENT BEING ON ANTICOAGULANTS. WITHOUT A LOT NUMBER TO CONDUCT A PHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED EVENTS COULD BE RELATED TO THE MANUFACTURING PROCESS. ADDITIONALLY, NEITHER PROCEDURAL IMAGES NOR FILMS WERE PROVIDED. THEREFORE, NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    AS PER, BIOPSY FORCEPS ACTIVE POST-MARKET SURVEILLANCE SURVEY REPORTED THEY HAVE EXPERIENCED PERICARDIAL TAMPONADE. ALSO , COMMENTING ¿PERICARDIAL EFFUSION FOLLOWED BY TAMPONADE DUE TO THE PATIENT BEING ON ANTICOAGULANTS.¿ THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954130 UNKNOWN BIOPSY FORCEPS DEVICE, BIOPSY, ENDOMYOCARDIAL DWZ CORDIS CORPORATION UNK-BIOPSYFORCEPS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other ANTICOAGULANTS.