BEUDAMED
    FDA Adverse Event Injury Summary report: N

    20/30 PRIORITY PACK W/COPILOT

    MDR report key: 2132764 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04303
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAV
    PMA / PMN Number
    K961471
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: A CINE OF THE PROCEDURE WAS RECEIVED AND REVIEWED BY AN ABBOTT CLINICAL SPECIALIST. THE REVIEWER NOTED THAT IT IS NOT POSSIBLE TO CONFIRM ANY ISSUE WITH THE INDEFLATOR FROM THE IMAGES. THERE IS A POSSIBILITY THAT THE STENT BALLOON SHAFT WAS KINKED OR THE BALLOON LUMEN COMPROMISED WHICH WOULD ALSO CAUSE THE SCENARIO REPORTED IN THE INCIDENT. REPORTEDLY, DISSECTION WAS OBSERVED AT THE STENT LOCATION DURING THE PROCEDURE AND THE PHYSICIAN BELIEVED THAT THE DISSECTION WAS CAUSED BY A HIGHER BALLOON PRESSURE THAN THE INACCURATE 12 ATMOSPHERES (ATM) READING ON THE GAUGE. IT IS UNKNOWN WHETHER THE INACCURATE GAUGE READING DID CONTRIBUTE TO THE DISSECTION AS REPORTED. EVALUATION OF THE RETURNED PRODUCT NOTED NO BLOOD OR CONTRAST VISIBLE. IT IS POSSIBLE THAT THE INDEFLATOR WAS WIPED DOWN PRIOR TO SHIPMENT TO ABBOTT VASCULAR FOR EVALUATION. THE WHITE HANDLE WAS INTACT WITH THE BLACK LOCKING MECHANISM. THE SCREEN AT THE BASE OF THE GAUGE WAS SEATED PROPERLY. THE BLACK LOCKING MECHANISM WAS IN A CLOSED POSITION AND THE GAUGE WAS OVER THE 30 ATM MARK. AN ATTEMPT WAS MADE TO DRAW IN FLUID INTO THE SYRINGE; HOWEVER, THE GAUGE WOULD NOT MOVE AND WAS STABLE OVER THE 30 ATM MARK. ADDITIONAL TESTING WAS PERFORMED BY ENGINEERING: THERE WAS A CRACK FOUND ON THE SYRINGE NEAR THE GATE OF THE INDEFLATOR CAUSING THE FLUID TO LEAK OUT OF THE SYRINGE. THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION AND LIKELY OCCURRED AFTER THE PROCEDURE OR DURING PACKING, HANDLING, AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. IN THIS CASE, IT WAS REPORTED THAT THE PHYSICIAN FURTHER USED THE INDEFLATOR FOR TESTING POST PROCEDURE WHICH COULD HAVE CONTRIBUTED TO THE NOTED CRACK ON THE INDEFLATOR. THE GAUGE FROM THE RETURNED INDEFLATOR WAS REMOVED AND MANUALLY PLACED THE NEEDLE OF THE GAUGE TO 0 ATM. THE RETURNED GAUGE WAS PLACED INSIDE A NEW INDEFLATOR AND ATTACHED A STOPCOCK AT THE HOSE. INFLATED THE INDEFLATOR UP TO 30 ATMS AND THE GAUGE WORKED PROPERLY. ATTACHED A NEW INDEFLATOR TO TEST FOR THE GAUGE READING AT 7 ATMS, 13 ATMS, 21 ATMS, 27 ATMS AND 30 ATMS. THE RETURNED GAUGE PROPERLY READ AT THE CORRECT PRESSURE. POTENTIAL FACTORS FOR INACCURATE GAUGE READING INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, FAULTY GAUGE, DAMAGE TO THE BOURDON TUBE OR DAMAGE TO THE GAUGE COMPONENTS. THERE WAS A CRACK FOUND ON THE SYRINGE NEAR THE GATE OF THE INDEFLATOR CAUSING THE FLUID TO LEAK OUT OF THE SYRINGE. THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION AND LIKELY OCCURRED AFTER THE PROCEDURE OR DURING PACKING, HANDLING, AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THE LOT HISTORY RECORD WAS REVIEWED AND THERE ARE NO NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE WERE NO OTHER INCIDENTS REPORTED FOR THIS LOT. A DEFINITIVE CAUSE FOR THE GAUGE ANOMALY COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER DEPLOYMENT OF A NON-ABBOTT STENT IN THE RIGHT CORONARY ARTERY, THE BALLOON WAS OBSERVED TO STILL BE INFLATED EVEN THOUGH THE INDEFLATOR WAS AT NEGATIVE PRESSURE AND THE GAUGE READ BELOW 0 ATMOSPHERES (ATM). THE BALLOON WAS FINALLY DEFLATED AFTER SEVERAL ATTEMPTS. AT THIS TIME A DISSECTION WAS OBSERVED AT THE STENT LOCATION. THE PHYSICIAN BELIEVES THAT THE DISSECTION WAS CAUSED BY A HIGHER BALLOON PRESSURE THAN THE INCORRECT 12 ATM READING ON THE GAUGE. A NON-ABBOTT STENT WAS USED TO TREAT THE DISSECTION AND A NEW INDEFLATOR WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    REPORTED INFORMATION INDICATES THAT ALTHOUGH THE APPROXIMATE LENGTH OF THE PROCEDURE WAS LESS THAN 30 MINUTES, A SIGNIFICANT CLINICAL DELAY OCCURRED IN THE PROCEDURE. SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL REPORTED INFORMATION INDICATES THAT THE 20/30 PRIORITY PACK INDEFLATOR WAS TESTED BY THE PHYSICIAN AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 20/30 PRIORITY PACK W/COPILOT ACCESSORY KIT MAV AV-TEMECULA-CT 0043094

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STENT: TSUNAMI GOLD (TERUMO)