BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2182166 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05341
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 NOT RETURNED FOR INVESTIGATION; THEREFORE, WITHOUT THE PRODUCT TO EXAMINE, NO DETERMINATION CAN BE MADE AS TO THE CAUSE OF THE REPORTED DISCREPANCY. THE RETURN OF THE DEVICE AND SUTURE MAY HAVE AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE PRODUCT EXPERIENCE. TO ENSURE THIS TYPE OF EXPERIENCE IS NOT THE RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, SAMPLINGS OF FINISHED DEVICES ARE TESTED TO VERIFY FUNCTIONALITY OF THE DEVICE. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU), STATES TO NOT USE THE PERCLOSE PROGLIDE SMC SYSTEM IF THE PUNCTURE IS THROUGH THE POSTERIOR WALL OR IF THERE ARE MULTIPLE PUNCTURES, SINCE SUCH PUNCTURES MAY RESULT IN A RETROPERITONEAL HEMATOMA. DEVIATING FROM THE IFU MAY HAVE BEEN A CONTRIBUTING FACTOR. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. THE LOT NUMBER IS UNKNOWN BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE LOT NUMBER WAS NOT REPORTED. BASED ON THE INFORMATION AVAILABLE AND THE INSPECTION CRITERIA THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY DEFICIENCY. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO A 100% INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DIAGNOSTIC LEFT HEART CATHETERIZATION THROUGH A 6F PROCEDURAL SHEATH, ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ACHIEVED USING A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, TWO DAYS LATER, THE PATIENT RETURNED TO THE HOSPITAL COMPLAINING OF INCREASING SORENESS AND PAIN AT THE ARTERIOTOMY SITE. THE PATIENT WAS READMITTED FOR EMERGENT EXPLORATORY ANGIOGRAPHY, WHICH REVEALED AN OCCLUSION FROM AN UNKNOWN MATERIAL AT THE ACCESS SITE. BECAUSE THE OCCLUDING MATERIAL COULD NOT BE IDENTIFIED, AN EMBOLIC PROTECTION DEVICE, EMBOSHIELD NAV6, WAS PLACED PROXIMAL TO THE OCCLUDED AREA IN THE VESSEL; HOWEVER, SUTURE FROM THE PROGLIDE DEVICE WAS FOUND DEPLOYED THROUGH THE BACK WALL OF THE COMMON FEMORAL ARTERY THAT CAUSED THE OCCLUSION. AFTER SUCCESSFUL REVASCULARIZATION WITH A BALLOON DILATATION CATHETER, AN ATTEMPT WAS MADE TO REMOVE THE EMBOSHIELD NAV6 FILTER ELEMENT. HOWEVER, AFTER FULLY ENCLOSING THE FILTER ELEMENT WITHIN THE RETRIEVAL CATHETER, THE DEVICE WAS BEING REMOVED OVER THE BAREWIRE BUT THE RETRIEVAL CATHETER ACCORDIONED, AND COULD NOT BE REMOVED THROUGH THE GUIDE CATHETER. THE FILTER ELEMENT, BAREWIRE, AND GUIDE CATHETER WERE REMOVED AS ONE UNIT. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN STATED THAT HE DID NOT FORCEFULLY PULL THE RETRIEVAL CATHETER INTO THE GUIDE CATHETER AND HE DID NOT ENCOUNTER ANY RESISTANCE DURING ADVANCEMENT OR WITHDRAW OF THE RETRIEVAL CATHETER. THE PHYSICIAN IS TRAINED IN BOTH THE EMBOSHIELD NAV6 AND PROGLIDE DEVICES. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R PROCEDURAL SHEATH 6F