BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2160171 · Received July 13, 2011

    Report

    Report Number
    2024168-2011-04942
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 29, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INSPECTION OF THE RETURNED DEVICE REVEALED THAT BOTH CUFFS SUCCESSFULLY CAPTURED THE NEEDLES DURING THE PLUNGER DEPLOYMENT. HOWEVER, THE LINK BROKE AT THE SWAGE END OF THE POSTERIOR CUFF WHILE RETRACTING THE NEEDLE PLUNGER, WHICH SUBSEQUENTLY RESULTED IN A FAILURE TO RETRIEVE THE SUTURE AND COULD APPEAR VERY SIMILAR TO THE REPORTED CUFF MISS. BECAUSE THE SUTURE COULD NOT BE RETRIEVED, THE KNOT WOULD NOT FORM TO ADVANCE TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL AS INTENDED. A LINK BREAK SUGGESTED THAT THERE WAS RESISTANCE ENCOUNTERED WHILE RETRACTING THE NEEDLE PLUNGER TO RETRIEVE THE SUTURE. POSSIBLE CONTRIBUTING FACTORS INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING DEFICIENCIES, CHALLENGING ANATOMICAL CONDITIONS, AND DEPLOYMENT TECHNIQUES. THE SUTURE WAS RETURNED INTACT. THERE WAS NO INDICATION THAT IT WAS DRAGGED THROUGH THE DEVICE DURING THE SUTURE RETRIEVAL PROCESS, WHICH COULD HAVE CONTRIBUTED TO THE LINK BREAK. THERE WAS NO DAMAGE OBSERVED AT THE SUTURE BEARING TO SUGGEST THAT THE SUTURE OR LINK WAS DRAGGED THROUGH THE SUTURE BEARING. EVERY LINK ASSEMBLY IS APPROPRIATELY INSPECTED AND TESTED FOR PROPER ASSEMBLY DURING MANUFACTURING. DURING TESTING, THE PLUNGER WAS INSERTED AND RETRACTED SUCCESSFULLY WITHOUT ANY OBSERVABLE RESISTANCE. THERE WERE NO REPORTED CHALLENGING ANATOMICAL CONDITIONS, WHICH COULD HAVE CONTRIBUTED TO THE LINK BREAK. THERE WAS NO INFORMATION REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE DEVICE TO SUGGEST THAT THE NEEDLE PLUNGER WAS ABRUPTLY PULLED OUT OF THE DEVICE AFTER NEEDLE DEPLOYMENT, WHICH COULD HAVE CAUSED THE LINK TO DETACH AT THE SWAGE END OF THE POSTERIOR CUFF. BASED ON THE REPORTED INFORMATION AND THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR THE LINK BREAK AT THE SWAGE END OF THE POSTERIOR CUFF COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. 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 FOR THIS LOT REVEALED NO 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 OTHER TWO PERCLOSE PROGLIDE DEVICES ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. 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 A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE USING A PROGLIDE DEVICE IN THE COMMON FEMORAL ARTERY AFTER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY IN THE SUPERFICIAL FEMORAL ARTERY. REPORTEDLY, A CUFF MISS OCCURRED. THE PROGLIDE WAS REMOVED AND A SECOND AND THIRD PROGLIDE WERE USED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING A FOURTH PROGLIDE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. 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
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 040076H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F| CLOPIDOGREL