BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2152025 · Received July 7, 2011

    Report

    Report Number
    2024168-2011-04793
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 16, 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
    CO, 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 WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND THAT THE PLUNGER, LINK, ANTERIOR NEEDLE, AND BOTH CUFFS WERE NOT RETURNED LIMITING THE SCOPE OF THIS INVESTIGATION. THE INSPECTION INDICATED THAT AN INCOMPLETE BLOW-THROUGH OCCURRED AS THE POSTERIOR NEEDLE TIP WAS CAUGHT IN THE POSTERIOR FOOT POCKET INSTEAD OF COMPLETELY EJECTED OUT OF THE POCKET WHEN DEPRESSING THE PLUNGER TO DEPLOY THE NEEDLES. SUBSEQUENTLY, WHEN THE PLUNGER WAS REMOVED FROM THE DEVICE, THE LINK WAS HELD ON ONE END BY THE POSTERIOR CUFF CAPTURING THE POSTERIOR NEEDLE IN THE FOOT POCKET WHILE BEING PULLED ON THE OTHER END BY THE WITHDRAWAL OF THE PLUNGER. THIS RESULTED IN THE POSTERIOR CUFF DETACHING FROM THE NEEDLE AS EVIDENCED BY THE DAMAGED POSTERIOR NEEDLE BARB. AN INCOMPLETE BLOW-THROUGH AND SUBSEQUENT POSTERIOR CUFF-TO-NEEDLE TIP DETACHMENT WOULD RESULT IN A FAILURE TO RETRIEVE THE SUTURE DURING THE PLUNGER RETRACTION, WHICH COULD APPEAR VERY SIMILAR TO THE REPORTED CUFF MISS. CONTRIBUTING FACTORS FOR A FAILURE TO EJECT THE POSTERIOR NEEDLE OUT OF THE POSTERIOR FOOT POCKET DURING NEEDLE DEPLOYMENT MAY INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, ANATOMICAL CONDITIONS AND/OR DEPLOYMENT TECHNIQUE. AS THE PLUNGER WAS NOT RETURNED WITH THE DEVICE, IT COULD NOT BE DETERMINED IF THERE WAS EXCESSIVE LOCTITE PRESENT IN THE NEEDLE SHANK WHICH COULD PREVENT THE PUSH MANDREL FROM TRAVELING COMPLETELY TO THE DISTAL END TO EJECT THE POSTERIOR NEEDLE OUT OF ITS POCKET. HOWEVER, DURING MANUFACTURING, LOCTITE WAS VERIFIED TO BE PROPERLY PLACED ON EVERY NEEDLE SHANK AND THE COMPLETE PUSH MANDREL TRAVEL WAS ALSO VERIFIED. DURING TESTING OF THE RETURNED DEVICE, A PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLES TRAJECTORY AND PUSH MANDREL TRAVEL AND THE RESULTS MET THE MANUFACTURING CRITERIA. THERE WAS NO INFORMATION REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE THAT SUGGESTED INCORRECT TECHNIQUE. AS REPORTED, THE PATIENT WAS OBESE AND HAD A HISTORY OF PERIPHERAL VASCULAR DISEASE AND PRIOR ARTERIOTOMY IN THE TARGET GROIN. THIS COULD CONTRIBUTE TO THE DETECTED DEVICE FAILURE, BUT COULD NOT BE CONFIRMED. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR A FAILURE TO EJECT THE POSTERIOR NEEDLE OUT OF THE POSTERIOR FOOT POCKET AND SUBSEQUENT POSTERIOR CUFF-TO-NEEDLE TIP DETACHMENT COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. A REVIEW OF THE PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NON-NONCONFORMING MATERIAL RECORDS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT AND ACTUAL INVESTIGATION FINDINGS. A QUERY OF THE COMPLAINT-HANDLING DATABASE FOR THIS LOT BASED ON ACTUAL INVESTIGATION FINDINGS REVEALED NO OTHER INCIDENTS THAT EXHIBITED A MISLOCATED POSTERIOR NEEDLE CAUGHT IN THE POSTERIOR FOOT POCKET AND SUBSEQUENT POSTERIOR CUFF-TO-NEEDLE TIP DETACHMENT. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. MANUAL ARTERIAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 030126H

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention SHEATH: 6F