BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2854215 · Received December 3, 2012

    Report

    Report Number
    2024168-2012-07628
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 27, 2012
    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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT OF BENT NEEDLES WAS NOT CONFIRMED AS THE PLUNGER WAS NOT RETURNED; HOWEVER THE REPORT OF NO SUTURE ATTACHED TO THE NEEDLE WAS CONFIRMED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. PATIENT REPORTED TO BE OF AVERAGE WEIGHT. 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. IT WAS REPORTED THE LEFT COMMON FEMORAL ARTERY WAS MILDLY CALCIFIED. PER THE INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. THE OTHER FOUR PROGLIDE DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WAS ATTEMPTED WITH THE PROGLIDE DEVICE IN THE LEFT COMMON FEMORAL ARTERY (LCFA) USING THE PRECLOSE TECHNIQUE PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR. THE ARTERIOTOMY WAS 6 FR AND THE LCFA WAS MILDLY CALCIFIED AND NON-TORTUOUS. REPORTEDLY, WHEN DEPLOYING THE PLUNGER, THE PHYSICIAN REPORTED IT DID NOT FEEL RIGHT, DID NOT SOUND RIGHT AND WHEN THE PLUNGER WAS RETRACTED THE NEEDLES WERE BENT AND THERE WAS NO SUTURE ATTACHED TO THE NEEDLE. ADDITIONAL 4 PROGLIDE DEVICES WITH THE SAME LOT NUMBER WERE ATTEMPTED WITH THE SAME RESULT. THE PHYSICIAN PERFORMED A CUT DOWN PROCEDURE, THE ARTERY WAS NOT IMPAIRED FROM THE PROGLIDE DEVICES, NOR ANYTHING TO EXPLAIN THE FAILED DEVICES. THE SHEATH WAS UPSIZED TO 14 FR TO PERFORM THE INDEX PROCEDURE. UPON COMPLETION OF THE AAA PROCEDURE THE LCFA WAS CLOSED SURGICALLY. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OF 30 MINUTES; HOWEVER, THERE WAS NO ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE 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 20808J1

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention SHEATH: 6F, 14FHEPARIN