BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2941843 · Received February 4, 2013

    Report

    Report Number
    2024168-2013-00616
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: LOT NUMBER. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. BASED ON THE INVESTIGATION FINDINGS, THE LINK WAS PULLED AT THE POSTERIOR CUFF. THE LINK CONNECTS THE ANTERIOR NEEDLE TO THE SUTURE; IF THE LINK IS PULLED FROM THE CUFF, THE SUTURE WILL NOT BE PRESENT DURING PLUNGER WITHDRAWAL AND CAN APPEAR VERY SIMILAR TO A SUTURE BREAK. THEREFORE, THE REPORTED SUTURE BREAK WAS NOT CONFIRMED, BUT THE EFFECTS OF THE LINK DETACHMENT APPEARED TO THE USER AS A SUTURE BREAK. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ONE UNUSED STERILE PROGLIDE DEVICE WITH LOT NUMBER, 21126J1, WAS RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED AND THE DEVICE PASSED WITH ACCEPTABLE RESULTS. NO MANUFACTURING OR ABNORMAL OBSERVATIONS WERE DETECTED. A CAUSE FOR THE COMPLAINT DEVICE REPORTED EXPERIENCE COULD NOT BE DETERMINED BASED ON THE INVESTIGATION FINDINGS FROM THE TESTED SAMPLE. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE WITH A 6F SHEATH AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE DEVICE HAD BEEN INTRODUCED OVER A STANDARD GUIDE WIRE. THE GUIDE WIRE WAS REMOVED AT SKIN LEVEL AND THE DEVICE PUSHED FORWARD UNTIL BLOOD MARKING WAS VISIBLE AT THE MARKER LUMEN. THE DEVICE WAS THEN PULLED BACK UNTIL THERE WAS NO MORE MARKING VISIBLE. THERE WAS NO PROBLEM DURING NEEDLE DEPLOYMENT. THE BLUE RAIL SUTURE WAS LOADED INTO THE SUTURE TRIMMER AND THE KNOT WAS ADVANCED FORWARD TO THE ARTERIOTOMY. THE BLUE RAIL SUTURE WAS WRAPPED AROUND THE LEFT FOREFINGERS, PLACING THE SUTURE TRIMMER UNDER THE LEFT THUMB TO ASSUME A SINGLE-HANDED POSITION AND COMPLETED KNOT ADVANCEMENT; HOWEVER, THE SUTURE BROKE AT THE DISTAL END. THE PHYSICIAN GRABBED THE REMAINING SUTURE AND THERE WAS A NEW SUTURE THREAD UNDER THE SKIN. HEMOSTASIS WAS ACHIEVED USING MANUAL ARTERIAL COMPRESSION. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE WITH A 6F SHEATH AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE DEVICE HAD BEEN INTRODUCED OVER A STANDARD GUIDE WIRE. THE GUIDE WIRE WAS REMOVED AT SKIN LEVEL AND THE DEVICE PUSHED FORWARD UNTIL BLOOD MARKING WAS VISIBLE AT THE MARKER LUMEN. THE DEVICE WAS THEN PULLED BACK UNTIL THERE WAS NO MORE MARKING VISIBLE. THERE WAS NO PROBLEM DURING NEEDLE DEPLOYMENT. FOLLOWING NEEDLE DEPLOYMENT THE PHYSICIAN GENTLY PULLED ON THE BLUE RAIL SUTURE WITH HIS LEFT HAND, KEEPING THE SUTURE COAXIAL TO THE TISSUE TRACT AND REMOVED THE DEVICE. IT WAS THEN NOTICED THAT THE SUTURE HAD NOT CAPTURED THE VESSEL WALL TO ACHIEVE HEMOSTASIS. HEMOSTASIS HAS BEEN ACHIEVED USING MANUAL ARTERIAL COMPRESSION. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46057 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 21006J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6FBIVALIRUDIN