BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2131306 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04247
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 24, 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 OTHER PERCLOSE PROGLIDE DEVICE IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. EVALUATION OF THE RETURNED DEVICE INDICATED THAT BOTH CUFFS SUCCESSFULLY CAPTURED THE NEEDLES DURING NEEDLE DEPLOYMENT; HOWEVER, THE ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT OCCURRED WHEN THE NEEDLE PLUNGER WAS RETRACTED AS EVIDENCED BY DAMAGED ANTERIOR CUFF TABS. THIS COULD APPEAR VERY SIMILAR TO THE REPORTED ANTERIOR CUFF MISS. THE RETURNED PLUNGER WITH ATTACHED LINK ASSEMBLY WAS UNMATCHED WITH THE DEVICE AS IT REVEALED THAT THE ANTERIOR CUFF REMAINED SECURELY ENGAGED WITH THE ANTERIOR NEEDLE. CUFF-TO-NEEDLE TIP DETACHMENT SUGGESTED THAT THERE WAS RESISTANCE ENCOUNTERED WHILE RETRACTING THE NEEDLE PLUNGER TO RETRIEVE THE SUTURE. DURING TESTING, A PROXY PLUNGER WAS INSERTED AND RETRACTED SUCCESSFULLY WITHOUT ANY OBSERVABLE RESISTANCE. THE SUTURE WAS RETURNED OUTSIDE THE DEVICE UNDAMAGED AND THERE WAS NO INDICATION THAT THE SUTURE MIGHT HAVE BEEN DRAGGED THROUGH THE DEVICE DURING THE SUTURE RETRIEVAL PROCESS WHICH COULD CONTRIBUTE TO CUFF-TO-NEEDLE TIP DETACHMENT. BASED ON OUR INVESTIGATION, A CAUSE FOR THE ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT COULD NOT BE DETERMINED. HOWEVER, POSSIBLE CAUSES FOR CUFF-TO-NEEDLE TIP DETACHMENT WHILE RETRACTING THE NEEDLE PLUNGER INCLUDED, BUT NOT LIMITED TO, CHALLENGING ANATOMICAL CONDITIONS OR ABRUPTLY PULLING OUT THE NEEDLE PLUNGER AFTER NEEDLE DEPLOYMENT, BUT NEITHER OF THESE COULD BE CONFIRMED. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. PER THE INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE DEVICE HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. A REVIEW OF THE PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORD WHICH WAS RELATED TO THIS EVENT. A QUERY OF THE COMPLAINT DATABASE WAS PERFORMED AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    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 CALCIFIED RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AN ANTERIOR CUFF MISS OCCURRED AS THE SUTURE WAS NOT RETRIEVED ON THE ANTERIOR NEEDLE WHEN THE PLUNGER WAS REMOVED. ANOTHER PROGLIDE WAS USED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING A STARCLOSE SE DEVICE. 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 860226H

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention ANGIOMAX