BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2103440 · Received May 26, 2011

    Report

    Report Number
    2024168-2011-03708
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THE LINK HAD BROKEN FROM THE POSTERIOR CUFF. THE ANTERIOR CUFF WAS CAPTURED AND ATTACHED TO THE NEEDLE TIP WITH THE LINK. A LINK BREAK WILL RESULT IN A FAILURE TO RETRIEVE THE SUTURE DURING PLUNGER REMOVAL AND CAN APPEAR VERY SIMILAR TO THE REPORTED SUTURE BREAK. HOWEVER, THE REPORTED CUFF MISS COULD NOT BE CONFIRMED. NO DEVICE DEFICIENCY WAS DETECTED DURING THE EXAMINATION OF THE RETURNED DEVICE. A LINK BREAK CAN BE INFLUENCED BY, BUT NOT LIMITED TO, MANUFACTURING, EXCESSIVE FORCE DURING PLUNGER REMOVAL, JERKY MOTION OR A SIDE WALL STICK, DEPLOYMENT IN CHALLENGING ANATOMIES (E.G. HEAVY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.). GENTLY REMOVING THE PLUNGER DURING THE FIRST 2 CM CAN REDUCE THE LINK BREAKAGE. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION BY MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. IT WAS REPORTED THAT THE ARTERY WAS HEAVILY CALCIFIED WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR IN THE EVENT; HOWEVER, IT COULD NOT BE CONCLUDED WHETHER THE PATIENT ANATOMY CONTRIBUTED TO THE LINK BREAK. NO MANUFACTURING OR QUALITY INSPECTION ISSUE WAS DETECTED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. BASED ON THE INVESTIGATION FINDINGS, THE LINK BREAK EXPERIENCED DURING THE PROCEDURE, SUBSEQUENT DAMAGE AND FAILURE TO ACHIEVE HEMOSTASIS WITH THE DEVICE, APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROSTAR XL DEVICE ATTEMPTED TO PERFORMED PRE-CLOSURE PLACEMENT OF THE SUTURES IN A HEAVILY CALCIFIED RIGHT AND LEFT COMMON FEMORAL ARTERY PRIOR TO AN ENDOVASCULAR PROCEDURE. REPORTEDLY, CUFF MISSES WERE EXPERIENCED WITH FOUR PROGLIDE DEVICES TWO ON THE RIGHT SIDE AND TWO ON THE LEFT SIDE. ONE PROGLIDE WAS SUCCESSFULLY PLACED IN THE RIGHT COMMON FEMORAL ARTERY AND TWO PROGLIDES WERE SUCCESSFULLY PLACED IN THE LEFT COMMON FEMORAL ARTERY TO ACHIEVE HEMOSTASIS. A 14F SHEATH WAS USED ON THE RIGHT SIDE AND AN 18F SHEATH WAS USED ON THE LEFT SIDE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT FILED, IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED TO PERFORM PRE-CLOSURE PLACEMENT OF THE SUTURES IN A HEAVILY CALCIFIED RIGHT AND LEFT COMMON FEMORAL ARTERY PRIOR TO AN ENDOVASCULAR PROCEDURE.

    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 860356H

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention HEPARIN