BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INQUIRY OPTIMA DIAGNOSTIC CATHETER

    MDR report key: 805368 · Received January 11, 2007

    Report

    Report Number
    2030404-2006-00008
    Event Type
    Injury
    Date Received
    January 11, 2007
    Date of Event
    November 22, 2006
    Report Date
    January 11, 2007
    Manufacturer
    IRVINE BIOMEDICAL, INC.(IBI)
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, BASED ON THE INFO PROVIDED, THERE IS NO INDICATION THAT THE OPTIMA CATHETER MALFUNCTIONED AS EVIDENCED BY THE PROPER DEFLECTION UPON REMOVAL OF THE OPTIMA. ALTHOUGH THE ACTUAL DEVICE WAS NOT RETURNED TO EVALUATE, SIMULATED BENCH TEST DATA IS AVAILABLE WITH A SIMILAR OPTIMA CATHETER AND A PORCINE ARTERY. DURING THE SIMULATION, THE DISTAL TIP OF THE CATHETER WAS MANIPULATED INSIDE THE ARTERY WITH AND WITHOUT A SHEATH, AND NO PERFORATION OR DAMAGE TO THE ARTERY WAS OBSERVED. CATHETERS ARE 100% INSPECTED IN-PROCESS AND AT FINAL INSPECTION FOR ELECTRICAL AND MECHANICAL INTEGRITY TO ENSURE THEY MET THE SPECIFICATION REQUIREMENTS. THE REVIEW OF DEVICE WORK ORDER INDICATES THAT ALL THE MFG AND INSPECTION PROCEDURES SUCH AS DIMENSIONAL, VISUAL AND FUNCTIONAL TESTS WERE PERFORMED AND THE LOT MET THE ACCEPTABLE REQUIREMENTS PRIOR TO RELEASE. IN ADDITION, THE OPTIMA DESIGN HAS BEEN VALIDATED TO MEET THE BUCKLING LOAD REQUIREMENT (SIMULATION OF FORCE REQUIRED TO PERFORATE TISSUE) OF LESS THAN 200G. A STRAIGHT (UNDEFLECTED) CATHETER WAS ALSO VALIDATED TO MEET THIS REQUIREMENT. DUE TO THE LOOP IN THE OPTIMA CATHETER, THE FORCE IS DISSEMINATED AROUND THE DISTAL LOOP MAKING THE POSSIBILITY OF PUNCTURE EVEN MORE REMOTE THAN WITH A STRAIGHT CATHETER. THERE ARE NO SHARP POINTS OF CONTACT AS THE CATHETER MAINTAINS THE DISTAL LOOP SHAPE. AS STATED IN THE INSTRUCTIONS FOR USE (IFU), "VASCULAR PERFORATION IS AN INHERENT RISK AND THAT THE CATHETER SHOULDN'T BE FORCED INTO THE VESSEL." DURING FOLLOWUP TO OBTAIN CLARIFICATION ON THE EVENT, IT WAS REPORTED THAT THE PHYSICIAN SUSPECTS THAT THE OPTIMA WAS DEPLOYED TOO CLOSE TO THE TOP OF THE AURICLE. RECORDINGS INDICATING THE POSITION OF THE CATHETER RELATIVE TO THE PUNCTURE SITE WAS REQUESTED, HOWEVER, WERE NOT AVAILABLE FOR REVIEW. THE RISK ASSESSMENT ASSOCIATED WITH OPTIMA AND CATHETERS WITH SIMILAR LOOP DESIGN WAS REVIEWED AND WITH REFERENCE TO OUR TESTING AND EXPERIENCE IDENTIFIES THAT THE LIKELIHOOD OF A HAZARD OF THIS NATURE RESULTING FROM OUR DEVICE, TAKING INTO ACCOUNT THIS EVENT AND OUR EXPERIENCE WITH SIMILAR DESIGN PRODUCT SHIPPED TO DATE, IS REMOTE. BASED ON THE INVESTIGATION, OUR CONCLUSION IS THAT THE OPTIMA DEVICE DID NOT MALFUNCTION AND THE REPORTED TAMPONADE WAS NOT CAUSED BY THE OPTIMA DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "FA ABLATION IN THE LEFT AURICLE. TAMPONADE AT THE BEGINNING OF THE PROCEDURE, JUST AFTER THE TRANSSEPTAL PUNCTURE WHEN THE OPTIMA CATHETER WAS DEPLOYED BY THE PHYSICIAN OUTSIDE THE SCHWARTZ SHEATH POSITIONED IN THE LEFT AURICLE. THE PROCEDURE WAS STOPPED. PERICARDIAL DRAINAGE, LEFT AURICLE CLOSURE BY STERNOTOMY. THE PHYSICIAN REPORTED THAT DURING THE PROCEDURE, IT SEEMS THE DISTAL END OF THE OPTIMA FASTENED ON TO THE TOP OF THE AURICLE AND AT THAT TIME, THE HANDLING BECAME DIFFICULT, SO THE PHYSICIAN DECIDED TO REMOVED THE OPTIMA IN ORDER TO CHECK ITS DEFLECTION WHICH LOOKED CORRECT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INQUIRY OPTIMA DIAGNOSTIC CATHETER ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER DRF IRVINE BIOMEDICAL, INC.(IBI) 81687 45436

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention