BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2192239 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05519
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DIFFICULTY IN REMOVING THE DEVICE CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO: MANUFACTURING, USER TECHNIQUE AND PATIENT ANATOMICAL CONDITIONS, EACH WERE CONSIDERED. REGARDING USER TECHNIQUE, NO INFORMATION WAS PROVIDED TO DETERMINE A POSSIBLE CAUSE RELATED TO IT. TISSUE COMPACTION THAT RESULTS IN A DISTAL FORCE BEING APPLIED TO THE LOCATOR WINGS, BENDING THEM DISTALLY, AND RESTRICTING THEIR PROPER RETRACTION INTO THE DELIVERY TUBE SET MAY CAUSE THE REPORTED DIFFICULTY IN REMOVING THE DEVICE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS, WHICH MAY HAVE ASSISTED IN THE INVESTIGATION; THEREFORE, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY IN REMOVING THE DEVICE AND THE SUBSEQUENT OOZING COULD NOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO NON-CONFORMING MATERIAL REPORTS WITH THIS LOT. THERE DOES NOT APPEAR TO BE AN INDICATION OF A PRODUCT QUALITY ISSUE. ALL DEVICES ARE VISUALLY TESTED DURING MANUFACTURING. IN ADDITION, A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. ESTIMATED AGE OF THE PATIENT WHO WAS REPORTED AS BEING IN HER LATE (B)(6). THE PATIENT WEIGHT WAS DESCRIBED AS NOT OBESE. THE CUSTOMER REPORTED THAT THE DEVICE WAS DISCARDED, THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE SAFETY AND EFFECTIVENESS OF THE STARCLOSE SE DEVICE HAS NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE. THE OTHER STARCLOSE SE IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED BILATERAL ARTERIOTOMY CLOSURE OF THE LEFT AND RIGHT COMMON FEMORAL ARTERIES (LCFA AND RCFA) AFTER A DIAGNOSTIC PROCEDURE USING STARCLOSE SE DEVICES. BOTH ARTERIES WERE DESCRIBED AS MODERATELY CALCIFIED, HOWEVER, IT WAS INDICATED THAT NEITHER ONE WAS CALCIFIED AT THE ACCESS SITE. THE PHYSICIAN REPORTED HE EXPERIENCED THE SAME DEVICE ISSUE IN BOTH GROINS; ONCE THE CLIP WAS DEPLOYED THE DEVICE BODY WAS STUCK IN THE PATIENT'S GROIN AND COULD NOT BE REMOVED. THE DEVICE SAFETY FEATURES WERE USED SUCCESSFULLY AND BOTH DEVICES CAME OUT OF THE PATIENT. TISSUE TRACT OOZING WAS ALTHOUGH OBSERVED AND ADJUNCTIVE COMPRESSION WAS APPLIED FOR 5 MINUTES IN THE RIGHT GROIN AND 10 MINUTES IN THE LEFT GROIN. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT. A 6 FR. SHEATH WAS USED ON EACH GROIN DURING VESSEL CLOSURE. THE PHYSICIAN IS TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 040406H

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention SHEATH: 6 FR X2.