BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2160009 · Received July 13, 2011

    Report

    Report Number
    2024168-2011-04939
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 10, 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
    GA, 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 DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE NOTED THAT BOTH CUFFS SUCCESSFULLY CAPTURED THE NEEDLES AND THE RAIL SUTURE END WAS CUT WITH THE DEVICE CUTTER. THIS IS INDICATIVE OF SUCCESSFUL NEEDLE DEPLOYMENT AND SUTURE RETRIEVAL. THE SUTURE KNOT WAS PROPERLY FORMED AND THERE WAS DRIED BLOOD PRESENT. THIS IS CONSISTENT WITH THE SUTURE BEING PULLED OUT OF THE ARTERY WHILE THE KNOT IS BEING ADVANCED TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL. SUBSEQUENTLY, HEMORRHAGE WOULD OCCUR DUE TO A FAILURE TO ACHIEVE HEMOSTASIS WHICH REQUIRED THE USE OF ADDITIONAL DEVICE AND THERAPY/NON-SURGICAL TREATMENT TO CLOSE THE VESSEL AS REPORTED. THE REPORT RECEIVED INDICATED THAT AN UNSPECIFIED DEVICE ISSUE OCCURRED. CONTRIBUTING FACTORS FOR THE SUTURE BEING PULLED OUT OF THE ARTERY DURING KNOT ADVANCEMENT INCLUDE, BUT NOT LIMITED TO: MANUFACTURING DEFICIENCIES; HOWEVER, THERE WERE NO DAMAGES TO THE DEVICE OR ITS COMPONENTS OBSERVED. ANATOMICAL CONDITIONS: AS REPORTED, THE PATIENT HAD PRIOR PROCEDURES IN THE TARGET GROIN AND THE ARTERY WAS SCARRED. THIS COULD CONTRIBUTE TO THE SUTURE BEING PULLED OUT OF THE ARTERY, BUT COULD NOT BE CONFIRMED. DEPLOYMENT TECHNIQUE: APPLYING EXCESSIVE FORCE ON THE SUTURE DURING THE KNOT ADVANCEMENT OR PLACEMENT COULD RESULT IN THE SUTURE BEING PULLED OUT OF THE ARTERY; 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 SUTURE BEING PULLED OUT OF THE ARTERY DURING THE KNOT ADVANCEMENT IS RELATED TO THE OPERATIONAL CONTEXT IN THE USE OF THE DEVICE. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. A REVIEW OF THE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF A SCARRED RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE USING A PROGLIDE DEVICE. REPORTEDLY, AN UNSPECIFIED DEVICE ISSUE OCCURRED. HEMOSTASIS WAS ACHIEVED USING ANOTHER PROGLIDE DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS. THE DEVICE WAS PICKED UP BY THE MANUFACTURER REPRESENTATIVE AND IT SEEMED TO HER THAT THE PLUNGER HAD BEEN PULLED TOO HARD AND THE SUTURE BROKE. THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE. A 6FR SHEATH WAS USED WITH THE CLOSURE 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 030266H

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention SHEATH: 6FR.