BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2233566 · Received September 2, 2011

    Report

    Report Number
    2024168-2011-06138
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RECEIVED IN A DEPLOYED STATE WITHOUT ANY MISSING COMPONENTS. THE ANTERIOR NEEDLE OF THE PLUNGER WAS ENGAGED WITH THE ANTERIOR CUFF WITH THE LINK AND POSTERIOR CUFF ATTACHED, WITHOUT THE POSTERIOR NEEDLE ENGAGED. THE SUTURE WAS RETURNED COMPLETE AND UNDAMAGED. THE SUTURE WAS MOSTLY DEPLOYED OUTSIDE OF THE DEVICE HANDLE BUT STILL ATTACHED TO THE HANDLE WITH THE POSTERIOR NEEDLE TIP ATTACHED AND EJECTED FROM THE POSTERIOR NEEDLE. BLOW THROUGH MARKS WERE PRESENT ON THE POSTERIOR FOOT, INDICATING PROPER POSTERIOR CUFF EJECTION FROM THE FOOT. THE POSTERIOR CUFF DID NOT PRESENT ANY DETECTED DAMAGE, BUT WAS IMPACTED WITH TISSUE. INSPECTION OF THE DEVICE FOOT ALSO DID NOT DETECT ANY DAMAGE TO EITHER FOOT POCKET; HOWEVER, THE POSTERIOR FOOT WAS IMPACTED WITH TISSUE. THERE WAS NO DETECTED HANDLE OR PLUNGER DAMAGE. THE RETURNED CONDITION OF THE DEVICE CONFIRMED THE REPORTED EVENT OF WHEN THE PLUNGER WAS PULLED OUT OF THE DEVICE BODY, THERE WAS NO SUTURE PRESENT. THE DEVICE WAS TESTED BY INSERTING THE PLUNGER/NEEDLE ASSEMBLY INTO THE DEVICE HANDLE, REQUIRING REMOVAL OF THE ANTERIOR CUFF FROM THE ANTERIOR NEEDLE, TO CHECK FOR NEEDLE TRAJECTORY, NEEDLE DEPTH AND PUSH MANDREL TRAVEL. THE TEST WAS SUCCESSFUL WITH ALL TESTING PARAMETERS MET. THE BLOW-THROUGH MARKS ON THE POSTERIOR FOOT INDICATED THE POSTERIOR CUFF WAS PROPERLY EJECTED FROM THE FOOT, ALSO INDICATING PROPER NEEDLE TRAJECTORY. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS VERIFIED TWICE DURING THE MANUFACTURING PROCESS TO HELP ENSURE PROPER NEEDLE PARAMETERS ARE MET. POSSIBLE CONTRIBUTING FACTORS THAT MAY RESULT IN A CUFF MISS/NO SUTURE PRESENT DURING PLUNGER RETRACTION INCLUDE, BUT ARE NOT LIMITED TO: MANUFACTURING, ANATOMICAL CONDITIONS, AND INCORRECT DEPLOYMENT TECHNIQUES. THE OBSERVED IMPACTED TISSUE WITHIN THE POSTERIOR FOOT AND CUFF IS THE MOST PROBABLE CAUSE FOR THE OBSERVED CUFF MISS AND IS RELATED TO THE OPERATIONAL CONTEXT IN THE USE OF THE DEVICE. REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THIS LOT REVEALED NO SIMILAR INCIDENTS AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE (CODE STEMI DIAGNOSTIC PROCEDURE WITH NO PERCUTANEOUS CORONARY INTERVENTION (PCI) . REPORTEDLY, WHEN THE PLUNGER WAS PULLED OUT OF THE DEVICE BODY, THERE WAS NO SUTURE PRESENT. A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT. A FEMORAL ANGIOGRAM WAS TAKEN PRIOR TO THE PROCEDURE, THERE WAS NO CALCIFICATION NEAR THE ARTERIOTOMY. A 6FR. SHEATH WAS USED DURING VESSEL CLOSURE. THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE. 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 040446H

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention SHEATH: 6 FR.