BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1971799 · Received January 27, 2011

    Report

    Report Number
    2024168-2011-00485
    Event Type
    Injury
    Date Received
    January 27, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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. (B)(4) - IMPROPER METHOD/OPERATOR NOT TRAINED. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. THE FIRST AND THIRD PERCLOSE (12673-03/940226H) ARE BEING FILED UNDER SEPARATE MFR NUMBERS.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INITIALLY THE DEVICE WAS REPORTED TO HAVE BEEN DISCARDED; HOWEVER, IT WAS RETURNED FOR EVALUATION. INSPECTION OF THE RETURNED DEVICE INDICATED THAT THE SUTURE KNOT WAS FORMED, BUT REMAINED WITH THE DEVICE. THE KNOT WAS NOT ADVANCED AND A SUTURE BREAK DURING THE KNOT ADVANCEMENT WAS NOT CONFIRMED. FURTHER INSPECTION REVEALED A LINK BREAK AT THE SWAGE END OF THE POSTERIOR CUFF WHILE RETRACTING THE NEEDLE PLUNGER. A LINK BREAK SUGGESTED THAT THERE WAS RESISTANCE ENCOUNTERED WHILE RETRACTING THE NEEDLE PLUNGER TO RETRIEVE THE SUTURE. HOWEVER, EVERY LINK ASSEMBLY IS APPROPRIATELY ASSEMBLED, INSPECTED, AND TESTED. ALSO, THE SUTURE BEARING WAS INSPECTED AND THERE WAS NO INDICATION THAT THE SUTURE OR LINK WAS DRAGGED THROUGH THE SUTURE BEARING WHICH COULD CAUSE THE LINK TO BREAK. DURING TESTING, THE PROXY PLUNGER WAS INSERTED AND RETRACTED SUCCESSFULLY WITHOUT ANY OBSERVABLE RESISTANCE AND THE SUTURE BEARING WAS INSPECTED AND THERE WAS NO OBSTRUCTION THAT COULD PREVENT THE SUTURE LOOP FROM BEING RELEASED FROM THE SUTURE BEARING. THE RETURNED CONDITION ALSO REVEALED THAT THE SUTURE KNOT WAS PROPERLY FORMED, BUT THE SUTURE LOOP REMAINED IN THE SUTURE BEARING, RESULTING IN THE SUTURE BEING REMOVED WITH THE DEVICE. THEREFORE, THE KNOT COULD NOT BE ADVANCED TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL AS INTENDED. CONTRIBUTING FACTORS FOR THE LINK BREAK DURING THE SUTURE RETRIEVAL PROCESS AND A FAILURE TO RELEASE THE SUTURE LOOP FROM THE SUTURE BEARING INCLUDED, BUT NOT LIMITED TO, MANUFACTURING DEFICIENCIES, ANATOMICAL CONDITIONS, DEPLOYMENT TECHNIQUE; HOWEVER THERE WAS NO INFORMATION REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE THAT SUGGESTED INCORRECT TECHNIQUE. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR THE LINK BREAK AT THE SWAGE END OF THE POSTERIOR CUFF COULD NOT BE DETERMINED. THE PROBABLE CAUSE FOR THE FAILURE TO RELEASE THE SUTURE LOOP FROM THE SUTURE BEARING IS INCORRECT TECHNIQUE AS THE DEVICE WAS DEPLOYED OUTSIDE THE ARTERY, RESULTING IN THE SUTURE WITH ITS KNOT BEING REMOVED ALONG WITH THE DEVICE. THEREFORE, THE KNOT COULD NOT BE ADVANCED TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL AS DESIGNED. THE INSTRUCTIONS FOR USE (IFU), UNDER THE CAUTION SECTION, STATES: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN (OR ALLIED HEALTHCARE PROFESSIONALS, AUTHORIZED BY, OR UNDER THE DIRECTION OF, SUCH PHYSICIANS) WHO IS TRAINED IN DIAGNOSTIC AND THERAPEUTIC CATHETERIZATION PROCEDURES AND WHO HAS BEEN TRAINED BY AN AUTHORIZED REPRESENTATIVE OF ABBOTT VASCULAR. ALSO, THE IFU, UNDER THE SMC DEVICE PLACEMENT SECTION, STATES: CONTINUE TO ADVANCE THE DEVICE JUST UNTIL A CONTINUOUS DRIP OF BLOOD IS EVIDENT FROM THE MARKER LUMEN. POSITION THE DEVICE AT A 45-DEGREE ANGLE. DEPLOY THE FOOT BY LIFTING THE LEVER (MARKED #1) ON TOP OF THE HANDLE. DO NOT DEPLOY THE FOOT UNLESS A CONTINUOUS DRIP OF BLOOD IS EVIDENT FROM THE MARKER LUMEN. GENTLY PULL THE DEVICE BACK TO POSITION THE FOOT AGAINST THE ARTERIAL WALL. IF PROPER POSITION OF THE FOOT HAS BEEN ACHIEVED, BLOOD MARKING WILL CEASE OR BE SIGNIFICANTLY REDUCED. IF MARKING DOES NOT STOP OR SIGNIFICANTLY CHANGE, GENTLY ADJUST THE ANGLE OF THE DEVICE TO STOP BLOOD MARKING. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT BASED ON ACTUAL INVESTIGATION FINDINGS REVEALED NO OTHER INCIDENTS THAT EXHIBITED A FAILURE TO RELEASE THE SUTURE LOOP FROM THE SUTURE BEARING AS THIS INCIDENT. OVERALL, IN REVIEW OF ALL INCIDENTS, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN UNTRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, DURING KNOT ADVANCEMENT, THE SUTURE BROKE. THE SAME EXPERIENCE OCCURRED FOR TWO OTHER PROGLIDE DEVICES. MANUAL COMPRESSION WAS APPLIED 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 940226H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DEVICE# 3: PERCLOSE ((B)(4))