BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2252495 · Received September 17, 2011

    Report

    Report Number
    2024168-2011-06387
    Event Type
    Injury
    Date Received
    September 17, 2011
    Date of Event
    August 26, 2011
    Report Date
    August 26, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE PLUNGER AND ITS ANTERIOR NEEDLE WERE NOT RETURNED. BOTH CUFFS SUCCESSFULLY CAPTURED THE NEEDLES DURING PLUNGER DEPLOYMENT. HOWEVER, THE ANTERIOR CUFF BECAME DETACHED FROM THE NEEDLE TIP WHILE RETRACTING THE NEEDLE PLUNGER TO RETRIEVE THE SUTURE, AS EVIDENCED BY THE DAMAGED ANTERIOR CUFF TABS. ONE OF THE ANTERIOR CUFF TABS (APPROXIMATELY 0.01 BY 0.01 INCHES) WAS BROKEN OFF AND WAS NOT RETURNED WITH THE DEVICE. SUBSEQUENTLY, A FAILURE TO RETRIEVE THE SUTURE OCCURRED, WHICH COULD APPEAR VERY SIMILAR TO THE REPORTED CUFF MISS. BECAUSE THE SUTURE COULD NOT BE RETRIEVED, THE KNOT WOULD NOT FORM TO ADVANCE TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL AS INTENDED. CUFF-TO-NEEDLE TIP DETACHMENT SUGGESTS THAT THERE WAS RESISTANCE ENCOUNTERED WHILE RETRACTING THE NEEDLE PLUNGER TO RETRIEVE THE SUTURE. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR THE ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT IS INCORRECT LINK ASSEMBLY DURING THE LINK LOADING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THIS LOT REVEALED NO SIMILAR INCIDENTS. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE ESTIMATED AGE OF THE PATIENT WAS REPORTED AS BEING IN THE (B)(6). THE ESTIMATED WEIGHT OF THE PATIENT WAS REPORTEDLY APPROXIMATELY (B)(6). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF A NON-CALCIFIED LEFT COMMON FEMORAL ARTERY (LCFA) WAS ATTEMPTED USING A PROGLIDE DEVICE, AFTER A DIAGNOSTIC LEFT HEART PROCEDURE. REPORTEDLY, A FEMORAL ANGIOGRAM WAS TAKEN AND THE PHYSICIAN OBSERVED THAT THE STICK PERFORMED AT THE GROIN WAS A LITTLE HIGH, AND DECIDED TO CONTINUE THE PROCEDURE. DURING PLUNGER RETRIEVAL FROM THE DEVICE BODY A CUFF MISS OCCURRED, THE DEVICE WAS REMOVED FROM THE PATIENT AND MANUAL ARTERIAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT. A 6 FR. SHEATH WAS USED DURING VESSEL CLOSURE. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE PROGLIDE DEVICE. 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 940316H

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention SHEATH: 6F.