BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2192332 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05526
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THAT THE WHOLE MONOFILAMENT WAS RETURNED LOOSE WITH THE NEEDLE TIP STILL ATTACHED TO THE RAIL END. THE ANTERIOR CUFF WAS ENGAGED TO THE ANTERIOR NEEDLE TIP AND BOTH CUFFS WERE ATTACHED TO THE LINK. THE POSTERIOR CUFF WAS OUT OF THE POCKET AND THE POSTERIOR CUFF TABS WERE UNDISTURBED, INDICATING THAT A POSTERIOR CUFF MISS OCCURRED AND THIS WOULD RESULT IN A FAILURE TO RETRIEVE THE SUTURE DURING THE NEEDLE PLUNGER RETRACTION. BECAUSE THE SUTURE COULD NOT BE RETRIEVED, THE KNOT WOULD NOT FORM TO ADVANCE TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL AS INTENDED. DURING THE INVESTIGATION, THE PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY, NEEDLE DEPTH AND PUSH MANDREL TRAVEL AND THE RESULTS WERE ACCEPTABLE. NO MANUFACTURING/QUALITY DEFICIENCY WAS DETECTED. THE MOST PROBABLE CAUSE FOR THE REPORTED AND CONFIRMED CUFF MISS IS NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE BECAUSE OF CHALLENGING ANATOMIES (E.G. HEAVY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.) OR FAILURE TO POSITION AND MAINTAIN THE DEVICE AT A 45 DEGREE ANGLE THROUGHOUT DEPLOYMENT. IT WAS REPORTED THAT THE FEMORAL TARGET ARTERY WAS MILDLY CALCIFIED, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PROGLIDE INSTRUCTIONS FOR USE (IFU) UNDER SPECIAL PATIENT POPULATIONS STATES THAT THE SAFETY AND EFFECTIVENESS OF THE PROGLIDE HAVE NOT BEEN ESTABLISHED IN THE FOLLOWING PATIENT POPULATIONS: PATIENTS WITH FEMORAL ARTERY CALCIUM, WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE. REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. TO HELP ENSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED DURING MANUFACTURING AND A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    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 RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF A MILDLY CALCIFIED RIGHT COMMON FEMORAL ARTERY (RCFA) USING A PROGLIDE DEVICE AFTER AN ANGIOPLASTY PROCEDURE OF A RIGHT MILDLY TORTUOUS, TOTALLY OCCLUDED CORONARY ARTERY. REPORTEDLY, DURING DEPLOYMENT STEP 2 (LIFT THE LEVER UP TO DEPLOY THE FOOT INSIDE THE ARTERY) THE PHYSICIAN INDICATED THE FEET DID NOT POSITION WELL IN THE ARTERY AND WHEN THE PLUNGER WAS RETRACTED FROM THE DEVICE BODY ONE OF THE NEEDLES HAD A SMALL PIECE OF THE WHITE LINK AND THE OTHER NEEDLE A PIECE OF THE BLUE SUTURE. THE DEVICE WAS REMOVED FROM THE PATIENT'S GROIN AND MANUAL ARTERIAL COMPRESSION WAS PERFORMED DURING 10-15 MINUTES TO ACHIEVE HEMOSTASIS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT. THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE. 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 870056H

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention SHEATH: 7 FR. OTHER: HEPARIN