BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1923330 · Received December 13, 2010

    Report

    Report Number
    2953144-2010-03205
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 18, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.THE FIRST STARCLOSE SE 14679-01/(B)(4), INDICATED IS BEING FILED UNDER A SEPARATE MFR#.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING CLOSURE OF BILATERAL (RIGHT AND LEFT) ARTERIOTOMY SITES IN THE SAME PATIENT USING TWO STARCLOSE SE DEVICES. (MFR REPORT NUMBERS 2953144-2010-03204 AND 2953144-2010-03205). INVESTIGATION OF THE RETURNED DEVICES NOTED ONE UNIT WAS A GEN 1A DEVICE AND THE OTHER WAS A GEN 3 DEVICE. EVALUATION FOUND THAT AN ATTEMPT HAD BEEN MADE TO ATTACH THE GEN 1A STARCLOSE CLIP APPLIER (GEN 1A CUTTER) TO A GEN 3 EXCHANGE SHEATH AND VICE VERSA. THE GEN 1A EXCHANGE SHEATH HAS A SMALLER HUB ENTRY LUMEN THAN THE GEN 3 EXCHANGE SHEATH AND WILL NOT ACCEPT A GEN 3 CLIP APPLIER BECAUSE THE GEN 3 CUTTER HAS A LARGER DIAMETER THAN THE GEN 1A EXCHANGE SHEATH HUB LUMEN. EVALUATION OF THE RETURNED DEVICE FOR MFR #2953144-2010-03205 FOUND THAT A GEN 1A CLIP APPLIER HAD BEEN ATTACHED TO A GEN 3 EXCHANGE SHEATH. THIS COMBINATION OF COMPONENTS WILL ALLOW THE EXCHANGE SHEATH TO BE INSTALLED OVER THE CUTTER BECAUSE THE GEN 1A CUTTER HAS A SMALLER DIAMETER AND CAN ENTER THE GEN 3 EXCHANGE SHEATH HUB LUMEN. IN COMPARING THE DEVICES RETURNED FOR THE INDICATED MFR REPORT NUMBERS, THE COMBINATIONS INDICATE THE EXCHANGE SHEATHS WERE INADVERTENTLY MIXED UP DURING THE PROCEDURE. THIS DEVICE WAS RECEIVED FULLY CLIP DEPLOYED; THE CLIP WAS NOT RETURNED. THE GEN 3 SHEATH WAS FULLY SLIT AND UNDAMAGED. THE DEVICE WAS TESTED FOR ITS REDEPLOYMENT CAPABILITIES. TESTING WAS SUCCESSFUL (MINUS THE CLIP) WITH COMPLETE DEVICE REDEPLOYMENT WITHOUT ANY DETECTED ANOMALY. THERE WAS NO RESISTANCE DETECTED TO ANY DEPLOYMENT OPERATION THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT FIND ANY INFORMATION RELEVANT TO THIS INVESTIGATION. A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE WERE NO OTHER CASES OF REPORTED SHEATH SPLITTING ISSUES WITH THE SAME LOT NUMBER. REFERENCING MFR #2953144-2010-03204, THE OTHER DEVICE USED DURING THIS PROCEDURE, THERE IS ONE LONE SIMILAR CASE (DIFFERENT LOT NUMBER) OF INCORRECT SHEATH TYPE USED FOR INSTALLATION ONTO A STARCLOSE SE DEVICE. BASED ON THE INVESTIGATION, THERE WAS NO MANUFACTURING OR QUALITY ISSUE AND THE DEVICE PERFORMED ACCORDING TO SPECIFICATION EVEN THOUGH THE IMPROPER EXCHANGE SHEATH HAD BEEN USED. THE ROOT CAUSE FOR THIS REPORTED EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE LAY REPORTER /MOTHER CONTACTED LFS ON (B)(6) 2010 ALLEGING INACCURATE HIGH READINGS HER SON'S ONE TOUCH ULTRASMART METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT AND SENT A LETTER TO OBTAIN FURTHER CLINICAL INFORMATION. THE FOLLOWING IS BASED ON THE INITIAL CALL PLACED BY THE PATIENT. THE REPORTER MENTIONED THAT THE ALLEGED ISSUE WITH THE METER BEGAN ON THE EVENING OF (B)(6) 2010. THE PATIENT HAD TESTED HIS BLOOD GLUCOSE AND OBTAINED A 126 MG/DL AND 20 MINUTES LATER DEVELOPED SYMPTOMS OF A HEADACHE AND A SEIZURE. PARAMEDICS WERE CALLED AND THE PATIENT'S BLOOD GLUCOSE WAS 59 MG/DL. THE PATIENT WAS TREATED WITH A GLUCAGON INJECTION. THE READING LATER WAS 86 MG/DL ON THE EMT'S METER AFTER TREATMENT. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THE COMPLAINT IS BEING REPORTED SINCE THE REPORTER ALLEGED THAT DUE TO THE HIGH READING, THE PATIENT HAD DEVELOPED SYMPTOMS AND HAD TO BE TREATED WITH A GLUCAGON INJECTION FOR A BLOOD GLUCOSE READING OF 59 MG/DL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE LEFT AND RIGHT COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE SHEATH DIDN'T SPLIT PROPERLY. A SECOND STARCLOSE SE DEVICE WAS USED. THE SHEATH DIDN'T SPLIT PROPERLY FOR THIS DEVICE AS WELL. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-REDWOOD CITY 860436H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention #1 STARCLOSE SE 14679-01/(B)(4)