BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELT ACD VASCULAR CLOSURE DEVICE

    MDR report key: 9217482 · Received October 22, 2019

    Report

    Report Number
    3009984513-2019-00008
    Event Type
    Injury
    Date Received
    October 22, 2019
    Date of Event
    September 25, 2019
    Report Date
    October 22, 2019
    Manufacturer
    VASORUM LTD.
    Product Code
    MGB
    UDI-DI
    05391530280228
    PMA / PMN Number
    P150006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THIS REPORT IS THE FINAL REPORT BEING SUBMITTED BY VASORUM UNLESS OTHERWISE REQUESTED BY THE FDA. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN THE CUSTOMER COMPLAINT FILES OF VASORUM LTD FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COMPLAINT INVOLVED A 6F DEVICE. DOCTOR MADE MULTIPLE ATTEMPTS TO ACCESS LEFT GROIN FOR RETROGRADE STICK WITH NO SUCCESS. SHIFTED TO RIGHT ANTEGRADE APPROACH AND ACCESSED AFTER MULTIPLE ATTEMPTS JUST DISTAL TO PRE-EXISTING ILIAC STENT. PROCEDURE COMPLETED WITH BALLOONING AND LASER ATHERECTOMY. SHEATH CONVERTED TO SHORT SHEATH FOR CELT CLOSURE. INITIAL SHEATH KINKED DUE TO ACUTE ACCESS TO VESSEL. CELT WOULD NOT PASS. WIRE RE-INTRODUCED AND SHEATH EXCHANGED. AFTER REPOSITIONING SHEATH MULTIPLE TIMES THE CELT DEVICE WAS PASSED AND MATED AT HUB. DOCTOR MADE ATTEMPT TO DEPLOY #1 DISC UNSUCCESSFULLY. BECAUSE OF SHARP ANGLE IT DIDN'T ALLOW FOR PROPER DEPLOYMENT OF #1. HANDLE TURNED BUT DISC NOT DEPLOYED. UPON ATTEMPTING TO ABORT CELT CLOSURE AND REMOVE SHEATH/DEVICE, #1 DISC DEPLOYED WHEN SHEATH WAS STRAIGHTENED. DOCTOR DREW DEVICE BACK TO POINT WHERE HE FELT HE WAS AT THE ARTERIOTOMY DUE TO INCREASED TENSION. DJ MEDICAL REP ADVISED HE WASN'T AT THE ARTERIOTOMY. IT WOULD NO LONGER PULL BACK AND APPEARED TO BE STUCK IN VESSEL APPROX. 3 MM DISTAL TO THE ARTERIOTOMY IN A LATERAL PROFILE. NOT NORMAL TO PROPER CLOSURE. DR MADE DECISION TO PROCEED WITH DEPLOYMENT OF #2 AND #3. DEVICE AND SHEATH REMOVED. DOCTOR STATED HE ACHIEVED HAEMOSTASIS AT ARTERIOTOMY. NOTED A LITTLE EXIT SITE BLEEDING. STAFF HELD PRESSURE FOR APPROX. 20 MIN. SITE RE-IMAGED TO CONFIRM LOCATION OF DEVICE AND IT STILL APPEARED TO BE IN LATERAL ASPECT IN AP VIEW. PATIENT STABLE AND TRANSPORTED TO RECOVERY. ONE HOUR LATER ULTRASOUND TECH NOTED REDUCED FLOW AT SITE OF CELT DEVICE. DR MADE DECISION TO TRANSPORT PATIENT TO ER AS HE FELT FURTHER ACCESS WOULD REQUIRE RADIAL APPROACH. ON 10TH OCTOBER WE WERE INFORMED THAT PATIENT HAD SURGERY AND IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012369 CELT ACD VASCULAR CLOSURE DEVICE VASCULAR CLOSURE DEVICE MGB VASORUM LTD. KCLT-06 750708 05391530280228

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention