BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1971111 · Received January 26, 2011

    Report

    Report Number
    2024168-2011-00473
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    December 23, 2010
    Report Date
    January 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. THE SECOND PERCLOSE PROGLIDE (PART# 12673-03, LOT# 940406H) IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED WITHOUT THE PLUNGER/NEEDLE ASSEMBLY, ANTERIOR AND POSTERIOR CUFFS, POSTERIOR NEEDLE TIP, LINK AND THE MAJORITY OF THE SUTURE MATERIAL, LIMITING THE SCOPE OF THIS INVESTIGATION. APPROXIMATELY 10 CM OF THE SUTURE WAS RETURNED. THERE WAS NO DETECTED DAMAGE TO THE DEVICE HANDLE, GUIDE TUBE, GUIDE, FOOT, OR SHEATH AND BLOW THROUGH MARKS WERE PRESENT ON THE POSTERIOR FOOT INDICATING POSTERIOR CUFF EJECTION FROM THE POSTERIOR FOOT. INSPECTION OF THE FOOT ASSEMBLY DID NOT DETECT ANY DAMAGE TO INDICATE A POSSIBLE CUFF MISS, NEEDLE STRIKE, OR POSSIBLE MALFUNCTION OF THE DEVICE. INSPECTION OF THE RETURNED SEGMENT OF SUTURE MATERIAL INDICATED CLEAN CUT TAIL ENDS AND NO SUTURE BREAK WAS DETECTED. THE DEVICE WAS TESTED BY INSERTING A PROXY PLUNGER/NEEDLE ASSEMBLY TO TEST FOR NEEDLE TRAJECTORY. THE TEST WAS SUCCESSFUL WITH BOTH, THE ANTERIOR AND POSTERIOR NEEDLES ENTERING THEIR RESPECTIVE FOOT POCKET INDICATING PROPER NEEDLE TRAJECTORY. FOR SUTURE BREAKS, POSSIBLE CAUSES ARE TOO MUCH TENSION APPLIED OR THE SUTURE IS NICKED; HOWEVER, NEITHER POSSIBILITY COULD BE CONFIRMED. USING SLOW, CONSTANT, INCREASING PRESSURE WHEN TIGHTENING THE SUTURE CAN PREVENT SUTURE BREAKS. BASED ON THE INVESTIGATION FINDINGS, THE REPORTED EVENT OF A SUTURE BREAK COULD NOT BE CONFIRMED. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE SUTURE BROKE. ANOTHER PROGLIDE DEVICE WAS USED WITH THE SAME RESULT. HEMOSTASIS WAS ACHIEVED USING A THIRD PROGLIDE. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 940406H

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention