BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2152758 · Received July 7, 2011

    Report

    Report Number
    2024168-2011-04816
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 16, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. ESTIMATED DATE OF EVENT ((B)(6) 2011). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. ADDITIONALLY, SIX UNUSED STERILE REPRESENTATIVE SAMPLE DEVICES WITH THE SAME PART NUMBER ARE RETURNING FOR EVALUATION; HOWEVER, HAVE NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). A CUFF MISS CAN BE INFLUENCED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO MANUFACTURING, HOWEVER, THE NEEDLE TRAJECTORY OF EVERY DEVICE WHICH MAY BE THE CAUSE FOR A CUFF-MISS, IS CHECKED DURING. ANOTHER CONTRIBUTING FACTOR TO THIS EVENT IS USER TECHNIQUE, SUCH AS, FAILURE TO POSITION AND MAINTAIN THE DEVICE AT A 45 DEGREE ANGLE THROUGHOUT DEPLOYMENT, ROTATING THE DEVICE AT ANY POINT DURING PLUNGER/NEEDLE DEPLOYMENT, AGGRESSIVELY DEPLOYING OR REMOVING THE PLUNGER AND/OR INADEQUATE POSITIONING OF THE FOOT AGAINST THE ARTERIAL WALL. HOWEVER, NO INFORMATION IN REGARDS TO THE USER TECHNIQUE WAS PROVIDED. PATIENT ANATOMY (E.G. HEAVILY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.) MAY CONTRIBUTE TO A CUFF MISS; HOWEVER, PATIENT MEDICAL HISTORY WAS NOT PROVIDED. PRODUCT WAS NOT RETURNED FOR ANALYSIS, WHICH MAY HAVE ASSISTED IN THE INVESTIGATION. NO INFORMATION CONCERNING USER TECHNIQUE, OR PATIENT ANATOMICAL CONDITION WAS PROVIDED. THEREFORE, A CONCLUSIVE CAUSE FOR THE REPORTED CUFF MISS COULD BE DETERMINED. FIVE OF THE SIX RETURNED DEVICES PASSED FUNCTIONAL TESTING WITHOUT ANY ISSUES. DURING TESTING OF ONE OF THE DEVICES FROM LOT 020346H, THE TECHNICIAN INADVERTENTLY FAILED TO STABILIZE THE DEVICE DURING PLUNGER REMOVAL, CREATING EXCESSIVE RESISTANCE ON THE NEEDLE-TO-CUFF ATTACHMENT, RESULTING IN DISENGAGEMENT OF THE NEEDLE TIP FROM THE CUFF. ANALYSIS CONFIRMED THE LACK OF STABILITY CAUSED THE DETACHMENT; THIS EVENT WAS UNRELATED TO THE REPORTED EXPERIENCE. NO MANUFACTURING OR ABNORMAL OBSERVATIONS WERE DETECTED. THERE WAS NO INDICATION DURING TESTING OF A PRODUCT QUALITY DEFICIENCY. THE REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD INDICATED ALL LOT RELEASE TESTING MET SPECIFICATION. THERE WAS NO MANUFACTURING OR QUALITY INSPECTION DEFICIENCY DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN USING THE PERCLOSE AT DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE PLUNGER WAS PULLED BACK NO SUTURES WERE ATTACHED TO THE NEEDLES; IT APPEARED TO BE A CUFF MISS. A SECOND PERCLOSE AT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PERCLOSE AT DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 010306H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention