BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOPSY FORCEPS

    MDR report key: 14197406 · Received April 25, 2022

    Report

    Report Number
    1016427-2022-05401
    Event Type
    Injury
    Date Received
    April 25, 2022
    Date of Event
    January 1, 1980
    Report Date
    May 9, 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

    BIOPSY FORCEPS ACTIVE POST-MARKET SURVEILLANCE SURVEY INDICATED THEY HAD EXPERIENCED PERMANENT ATRIAL VENTRICULAR BLOCK, HEMORRHAGES, PERICARDIAL EFFUSION, AND THROMBOSIS. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO LOT NUMBER WAS PROVIDED THEREFORE A PRODUCT HISTORY RECORD (PHR) REVIEW COULD NOT BE GENERATED. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS AND BASED ON THE INFORMATION PROVIDED, THE REPORTED ¿EMBOLISM¿ WAS NOT CONFIRMED. PROCEDURAL AND OR HANDLING FACTORS SUCH THE USER¿S INTERACTION WITH THE DEVICE MAY HAVE LED TO THE REPORTED EVENT. ADDITIONALLY, NO PROCEDURAL IMAGES OR FILMS HAVE BEEN MADE AVAILABLE. ACCORDING TO THE INSTRUCTIONS FOR USE ¿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 AND DEATH.¿ ADDITIONALLY, REFER TO THE ¿DESCRIPTION¿ SECTION FOR AID IN SELECTING THE SIZE OF THE SHEATH INTRODUCER AND BIOPSY FORCEPS TO BE USED. USING FLUOROSCOPY, ADVANCE THE FORCEPS THROUGH THE APPROPRIATE SHEATH INTRODUCER AND INTO THE RIGHT OR LEFT VENTRICLE. NOTE: WHEN USING THE 104 CM BIOPSY FORCEPS, CONFIRM THE POSITION OF THE SHEATH INTRODUCER IN THE VENTRICLE PRIOR TO EACH BIOPSY TO BE PERFORMED. AFTER CONFIRMING THAT THE TIP OF THE FORCEPS IS IN THE VENTRICLE, OPEN THE JAWS. ADVANCE THE OPEN JAWS TO THE HEART WALL. CLOSE THE JAWS FIRMLY TO OBTAIN A TISSUE SPECIMEN. MAINTAIN SUFFICIENT PRESSURE ON THE DOUBLE RINGS TO ASSURE RETENTION OF SPECIMEN DURING WITHDRAWAL. NOTE: CLOSING OF THE JAWS AND WITHDRAWAL OF THE BIOPTOME SHOULD BE PERFORMED IN A SINGLE MOTION. FLUSH THE SHEATH INTRODUCER CONTINUOUSLY WITH HEPARINIZED SALINE WHILE SLOWLY WITHDRAWING THE FORCEPS. REMOVE THE SAMPLE FROM JAWS. RINSE BIOPTOME BEFORE AND AFTER EACH BIOPSY. REPEAT STEPS 2 THRU 7 UNTIL SUFFICIENT TISSUE VOLUME IS OBTAINED. ¿NEITHER THE PHR REVIEW NOR THE INFORMATION AVAILABLE SUGGESTS A DESIGN OR MANUFACTURING RELATED CAUSE COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 0

    AS REPORTED, BIOPSY FORCEPS ACTIVE POST-MARKET SURVEILLANCE SURVEY INDICATED THEY HAD EXPERIENCED PERMANENT ATRIAL VENTRICULAR BLOCK, HEMORRHAGES, PERICARDIAL EFFUSION, AND THROMBOSIS. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    AS REPORTED, BIOPSY FORCEPS ACTIVE POST-MARKET SURVEILLANCE SURVEY INDICATED THEY HAD EXPERIENCED PERMANENT ATRIAL VENTRICULAR BLOCK, HEMORRHAGES, PERICARDIAL EFFUSION, AND THROMBOSIS. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127631 UNKNOWN BIOPSY FORCEPS DEVICE, BIOPSY, ENDOMYOCARDIAL DWZ CORDIS CORPORATION UNK-BIOPSYFORCEPS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other UNK.