BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2080728 · Received May 6, 2011

    Report

    Report Number
    2024168-2011-03256
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. SUBSEQUENTLY, AN AMENDED USER FACILITY MED WATCH REPORT WAS RECEIVED WITH ADDITIONAL INFORMATION STATING: DOCTOR WAS USING STARCLOSE DEVICE ON THE PATIENT WHEN THE DEVICE MALFUNCTIONED. THE PHYSICIAN WAS GOING THROUGH ALL THE STEPS. ON OR ABOUT STEP 2, THE PATIENT HAD SIGNIFICANT PAIN IN THE GROIN WHICH WAS VERBALIZED. WE ABORTED THE PROCEDURE AND REMOVED THE DEVICE WITHOUT DEPLOYING THE STARCLOSE. THE DEVICE WAS RETURNED TO THE BACK TABLE. THIS WAS WHEN A LARGE BARB WAS NOTICED ON THE DELIVERY TUBE. THE DEVICE WAS REMOVED AND RETAINED. THIS RESULTED IN A SKIN TEAR TO THE PATIENT. THE SKIN TEAR WAS MADE WORSE WITH PRESSURE BEING APPLIED. DOPPLER WAS GOOD. AREA WAS DRESSED. DOCTOR AWARE. PULSES GOOD. FOLLOW UP PHONE CALL WILL BE DONE ON THE DAY AFTER PROCEDURE. PATIENT CALLED FIVE DAYS LATER. ROOMMATE WAS CHECKING SITE AND REPORTED NO PROBLEMS, JUST PERFECT. PATIENT WAS DISCHARGED TO HOME WITH FOLLOW UP DISCHARGE CALL. POST DISCHARGE PHONE CALL WAS MADE. SIT STABLE, CARE WAS WONDERFUL. NO FURTHER QUESTIONS REGARDING DISCHARGE INSTRUCTIONS. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. ULTIMATELY, THE RETURN OF THE DEVICE MAY HAVE AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE EXPERIENCED EVENT. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT WERE RELATED TO THIS COMPLAINT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT AND WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED EXPERIENCE CANNOT BE DETERMINED. TO ENSURE THIS TYPE OF EXPERIENCE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, A SAMPLING OF FINISHED DEVICES IS ALSO TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE.

    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 COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE DEVICE 'FAILED'. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED. SUBSEQUENTLY, A USER FACILITY MED WATCH REPORT RECEIVED, STATING "DOCTOR WAS USING STARCLOSE DEVICE ON PATIENT WHEN THE DEVICE MALFUNCTIONED. DISPOSABLE DEVICE WAS REMOVED AND RETAINED. THIS RESULTED IN A SKIN TEAR TO THE PATIENT. THE SKIN TEAR WAS MADE WORSE WITH PRESSURE BEING APPLIED. DOPPLER WAS GOOD. AREA WAS DRESSED. DOCTOR AWARE. PULSES GOOD. FOLLOW UP PHONE CALL WILL BE DONE ON THE DAY AFTER PROCEDURE. PATIENT CALLED FIVE DAYS LATER. ROOMMATE WAS CHECKING SITE AND REPORTED NO PROBLEMS, JUST PERFECT. PATIENT WAS DISCHARGED TO HOME WITH FOLLOW UP DISCHARGE CALL. POST DISCHARGE PHONE CALL WAS MADE. SITE STABLE, CARE WAS WONDERFUL. NO FURTHER QUESTIONS REGARDING DISCHARGE INSTRUCTIONS. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 830336H

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention