BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2183056 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05363
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 8, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS OF THE DEVICE NOTED THAT BOTH CUFFS WERE CAPTURED AND ATTACHED TO THE NEEDLE TIP. THE SUTURE HAD BEEN HARVESTED AND CUT APPROXIMATELY 2 CM PROXIMAL OF THE POSTERIOR NEEDLE TIP. AS THE USER REPORTED THAT THE SUTURE WAS NOT RETRIEVED WHEN THE PLUNGER WAS REMOVED, A REQUEST FOR CLARIFICATION WAS MADE; NO ADDITIONAL INFORMATION WAS PROVIDED. A PORTION OF TISSUE WAS CAUGHT IN THE LOOP OF THE SUTURE AT THE POSTERIOR FOOT WHICH SUGGESTS THAT INSUFFICIENT TISSUE WAS CAPTURED RESULTING IN THE SUTURE PULLING OUT OF THE ARTERIOTOMY AS THE DEVICE WAS REMOVED. INCOMPLETE OR PARTIAL TISSUE CAPTURE CAN BE INFLUENCED BY, BUT IS NOT LIMITED TO, ANATOMICAL CONDITIONS, DEPLOYMENT TECHNIQUE SUCH AS APPLYING EXCESSIVE FORCE ON THE SUTURE DURING THE KNOT ADVANCEMENT OR PLACEMENT, DEPLOYMENT AT THE INCORRECT ANGLE (OTHER THAN 45 DEGREES), OR FAILURE TO STABILIZE THE DEVICE DURING DEPLOYMENT. REPORTEDLY, THE ACCESS SITE WAS NOTED AS CALCIFIED. THE INSTRUCTIONS FOR USE STATES THAT THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED IN THE PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. THE RETURN OF THE SUTURE WITH A PORTION OF TISSUE AT THE LOOP OF THE SUTURE INDICATES THE MOST LIKELY CAUSE OF THE REPORTED EXPERIENCE WAS DUE TO OPERATION INFLUENCES DURING DEPLOYMENT. THE ANALYSIS OF THE RETURNED DEVICE DID NOT INDICATE ANY EVIDENCE OF A PRODUCT QUALITY DEFICIENCY. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND 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 SUBJECTED TO INSPECTION DURING MANUFACTURING. THE NEEDLE TRAJECTORY IS INSPECTED DURING MANUFACTURING AND 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 HAS BEEN RECEIVED. INVESTIGATION IS NOT COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF THE CALCIFIED RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE SUTURE WAS NOT RETRIEVED WHEN THE PLUNGER WAS REMOVED. MANUAL PRESSURE AND A NON-ABBOTT DEVICE WERE USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. REPORTEDLY, THE PHYSICIAN IS TRAINED IN THE USE OF THE 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 040356H

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention SHEATH: 6F