BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2072885 · Received April 29, 2011

    Report

    Report Number
    2024168-2011-03001
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THAT IT HAD BEEN DEPLOYED, THE ANTERIOR CUFF HAD BEEN CAPTURED AND WAS ATTACHED TO THE NEEDLE TIP. HOWEVER, THE LINK HAD BROKEN FROM THE ANTERIOR CUFF DURING SUTURE HARVESTING. A LINK BREAK DURING NEEDLE RETRIEVAL AND A CUFF MISS HAVE THE SAME RESULT AND APPEARANCE DURING DEPLOYMENT; THEREFORE, THE REPORTED EXPERIENCE IS CONFIRMED. AN ANTERIOR LINK BREAK CAN ALSO BE CAUSE BY AN INITIAL POSTERIOR CUFF MISS. DURING NEEDLE TRAJECTORY TESTING THE PLUNGER WAS INSERTED INTO THE DEVICE AND THE TRAJECTORY, DEPTH AND MANDREL TRAVEL WERE ACCEPTABLE. THE NEEDLE TRAJECTORY OF EACH DEVICE IS INSPECTED DURING MANUFACTURING. DURING NEEDLE DEPLOYMENT (STEP 3), THE SUTURE IS HARVESTED AND PULLED THROUGH THE SUTURE BEARING AND ANTERIOR NEEDLE GUIDE; RESISTANCE AT THIS POINT OF DEPLOYMENT CAN CAUSE THE LINK TO DETACH OR BREAK. THIS MAY ACCOUNT FOR THE REPORTED INTERFACE EXPERIENCED AT THIS STEP. A LINK BREAK CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO; MANUFACTURING, FAILURE TO POSITION AND MAINTAIN THE DEVICE AT A 45 ANGLE THROUGHOUT DEPLOYMENT, ROTATING THE DEVICE AT ANY POINT DURING PLUNGER/NEEDLE DEPLOYMENT, DEPLOYMENT IN CHALLENGING ANATOMIES (E.G. HEAVY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.), AGGRESSIVELY DEPLOYING OR REMOVING THE PLUNGER AND/OR INADEQUATE POSITIONING OF THE FOOT AGAINST THE ARTERIAL WALL. BASED ON THE ANALYSIS THE PROBABLE CAUSE OF THE LINK DETACHMENT IS RELATED TO THE OPERATIONAL CONTEXT DURING USE. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO AN INSPECTION DURING MANUFACTURING. IN ADDITION, 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 WILL BE SUBMITTED WITH ALL ADDITIONAL, RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN IN TRAINING IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A CORONARY AND PULMONARY ANGIOPLASTY PROCEDURE. REPORTEDLY, DURING FOOT DEPLOYMENT, THE PHYSICIAN FELT AN 'INTERFACE'. WHEN THE PLUNGER WAS PULLED BACK, A CUFF MISS OCCURRED. A SECOND DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 960286H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VENOUS SHEATH: 10 FR