BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3231145 · Received July 17, 2013

    Report

    Report Number
    2024168-2013-04484
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 26, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). , ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE RETURNED CONDITION COULD NOT CONFIRM THE REPORTED SUTURE BEING UNRAVELED AS THE KNOT WAS PROPERLY FORMED AND REMAINED INTACT. INSPECTION OF THE RETURNED DEVICE INDICATED THAT THE POSTERIOR CUFF ALONG WITH ITS NEEDLE TIP WAS CAUGHT INSIDE THE KNOT DURING THE PLUNGER RETRACTION/SUTURE RETRIEVAL PROCESS. BECAUSE THE POSTERIOR CUFF WAS CAPTURED WITHIN THE KNOT, PULLING OUT THE PLUNGER WOULD HAVE RESULTED IN A LINK BREAK AT THE SWAGE END OF THE ANTERIOR CUFF. BASED ON THE REPORTED INFORMATION, MANUFACTURING INSPECTION CRITERIA AND ANALYSIS OF THE RETURNED DEVICE, THE PROBABLE CAUSE FOR THE POSTERIOR CUFF ALONG WITH ITS NEEDLE TIP BEING CAUGHT INSIDE THE KNOT WHICH DIRECTLY RESULTED IN A LINK BREAK AT THE SWAGE END OF THE POSTERIOR CUFF COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PLACEMENT OF THE PROGLIDE SUTURES WERE ATTEMPTED IN THE RIGHT COMMON FEMORAL ARTERY USING THE PERCLOSE TECHNIQUE PRIOR TO A DIAGNOSTIC PROCEDURE. THE ARTERIOTOMY WAS A 6FR. REPORTEDLY, THE SUTURE UNRAVELLED WHEN THE DEVICE WAS PULLED OUT AND COULD NOT BE ADVANCED. THE DIGNOSTIC PROCEDURE WAS COMPLETED AND A NON-ABBOTT 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 PROGLIDE 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
    331420 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30325K1

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention SHEATH: 6F