BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3250798 · Received July 29, 2013

    Report

    Report Number
    2024168-2013-04722
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SUTURE BREAK WAS NOT CONFIRMED AS ANALYSIS OF THE DEVICE INDICATED A POSTERIOR NEEDLE-TO-CUFF MISS OCCURRED. HOWEVER, A CUFF MISS CAN APPEAR SIMILAR TO THE OPERATOR AS A SUTURE BREAK. BASED ON VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE PROGLIDE DEVICE WAS REPORTEDLY DEPLOYED THROUGH A 4-FRENCH SIZED COMMON FEMORAL ARTERY ACCESS SITE. PER THE INDICATIONS SECTION OF THE INSTRUCTIONS FOR USE, THE PERCLOSE PROGLIDE SMC SYSTEM IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5F TO 21F SHEATHS. FOR SHEATH SIZES GREATER THAN 8 FR, AT LEAST TWO DEVICES AND THE PRE-CLOSE TECHNIQUE ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. (B)(4). THE PROGLIDE DEVICE WAS REPORTEDLY DEPLOYED THROUGH A 4-FRENCH SIZED COMMON FEMORAL ARTERY ACCESS SITE. PER THE INDICATIONS SECTION OF THE INSTRUCTIONS FOR USE THE PERCLOSE PROGLIDE SMC SYSTEM IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5F TO 21F SHEATHS. FOR SHEATH SIZES GREATER THAN 8 FR, AT LEAST TWO DEVICES AND THE PRE-CLOSE TECHNIQUE ARE REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DIAGNOSTIC PERIPHERAL ANGIOGRAM, ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, DURING DEPLOYMENT THE SUTURE BROKE. A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352802 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30218K1

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention SHEATH: 4-FRENCH