BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2944268 · Received February 5, 2013

    Report

    Report Number
    2024168-2013-00646
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 16, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED FAILURE TO DEPLOY THE SUTURES WAS CONFIRMED. BASED ON THE REPORTED INFORMATION, MANUFACTURING INSPECTION CRITERIA AND ANALYSIS OF THE RETURNED DEVICE, THE CAUSE WAS RELATED TO INCORRECT USER TECHNIQUE OF CLAMPING THE SUTURES DURING NEEDLE DEPLOYMENT. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE ANALYSIS ALSO REVEALED CLAMP MARKS AND DAMAGE SUTURE LUMENS AND IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) UNDER PRECAUTIONS STATES: AVOID CRUSHING DAMAGE DUE TO APPLICATION OF SURGICAL INSTRUMENTS SUCH AS FORCEPS OR NEEDLE HOLDERS. UNDER EXAMINATION AND SELECTION OF PRODUCTS THE IFU STATES; EXERCISE CARE WHEN USING ADDITIONAL SURGICAL INSTRUMENTS SUCH AS FORCEPS, HEMOSTATS OR NEEDLE HOLDERS DURING DEVICE HANDLING, TO REDUCE THE POSSIBILITY OF ACCIDENTAL DEVICE BREAKAGE. ALSO UNDER DEVICE PLACEMENT THE IFU STATES: DO NOT CLAMP THE SUTURE LUMEN WITH A HEMOSTAT OR OTHER INSTRUMENT. DOING SO WILL PREVENT SUTURE DEPLOYMENT. THE WARNINGS AND IFU THE USER TECHNIQUE WAS A CONTRIBUTING FACTOR IN THE REPORTED EXPERIENCE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PLACEMENT OF THE PROSTAR XL SUTURES WERE ATTEMPTED IN THE RIGHT COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO A ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. THE ARTERIOTOMY WAS 18FR SHEATH. REPORTEDLY, AFTER NEEDLE DEPLOYMENT, IT WAS NOTICED THAT THE SUTURES WERE TANGLED UP AND DID NOT COME OUT WITH THE DEVICE. A NEEDLE BACKDOWN WAS PERFORMED AND THE DEVICE WAS EASILY REMOVED. A SECOND PROSTAR XL DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROSTAR XL DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48218 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20918K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 18FR