BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2250432 · Received September 15, 2011

    Report

    Report Number
    2024168-2011-06336
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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: EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE POSTERIOR FOOT WAS COMPLETELY DETACHED AND NOT RETURNED WITH THE DEVICE. THE POSTERIOR NEEDLE WAS BROKEN AND THE TIP WAS DULL. THIS OBSERVED DAMAGE IS CONSISTENT WITH THE POSTERIOR NEEDLE BEING DEFLECTED AND STRIKING THE FOOT DURING NEEDLE DEPLOYMENT INSTEAD OF ENGAGING WITH THE POSTERIOR CUFF INSIDE THE POSTERIOR FOOT POCKET AS INTENDED. BECAUSE THE POSTERIOR NEEDLE DID NOT ENGAGE WITH THE POSTERIOR CUFF, THE CUFF WAS NOT EJECTED FROM THE FOOT. WHEN THE PLUNGER WAS REMOVED FROM THE DEVICE, THE LINK WAS HELD ON ONE END BY THE POSTERIOR CUFF IN THE POSTERIOR FOOT POCKET WHILE BEING PULLED ON THE OTHER END BY THE WITHDRAWAL OF THE PLUNGER. THIS RESULTED IN THE LINK DETACHING FROM THE SWAGE END OF THE ANTERIOR CUFF AS OBSERVED. NO MANUFACTURING/QUALITY DEFICIENCY WAS DETECTED AS A RESULT OF THIS INVESTIGATION. POSSIBLE CONTRIBUTING FACTORS FOR THE NEEDLE DEFLECTION THAT RESULTED IN A POSTERIOR FOOT BREAK AND SUBSEQUENT LINK-TO-ANTERIOR CUFF DETACHMENT INCLUDE, BUT ARE NOT LIMITED TO: MANUFACTURING, CHALLENGING ANATOMICAL CONDITIONS, AND INCORRECT DEPLOYMENT TECHNIQUES. THE REPORTED MILD CALCIFICATION AT THE ACCESS SITE, WHICH WAS PREVIOUSLY ACCESSED COULD HAVE CONTRIBUTED TO NEEDLE DEFLECTION DURING DEPLOYMENT; HOWEVER, THIS COULD NOT BE CONFIRMED. THE DEVICE INSTRUCTIONS FOR USE, STATES: THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE DEVICES HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE. THERE WAS NO DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE TO SUGGEST THAT THE DEVICE WAS TWISTED OR ROTATED OR THE NEEDLES WERE DEPLOYED WHEN THE DEVICE WAS NOT AT AN APPROXIMATE 45-DEGREE ANGLE, WHICH COULD HAVE CONTRIBUTED TO THE NEEDLE DEFLECTION. THE PROBABLE CAUSE FOR THE POSTERIOR FOOT BREAK THAT SUBSEQUENTLY RESULTED IN A LINK DETACHMENT IS NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT. 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. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS VERIFIED TWICE DURING MANUFACTURING. BASED ON THE INVESTIGATION, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF A MILDLY CALCIFIED LEFT COMMON FEMORAL ARTERY (LCFA), USING A PROGLIDE DEVICE, AFTER A RIGHT SUPERFICIAL FEMORAL ARTERY INTERVENTIONAL PROCEDURE. REPORTEDLY, THE PHYSICIAN DEPRESSED THE PLUNGER AND HEARD A CRUNCHING NOISE, HE INDICATED THAT THE NEEDLES HAD DEFLECTED AND THE DEVICE COULD BE REMOVED FROM THE PATIENT'S GROIN AS NOTHING WAS HOLDING IT IN PLACE. THE DEVICE WAS PULLED OUT WITH NO EFFORT AND IT WAS OBSERVED THAT ONE FOOT PIECE WAS MISSING. A VASCULAR SURGEON WAS CALLED IN, THE DEVICE PIECE WAS REMOVED FROM THE PATIENT'S GROIN AND THE LCFA WAS SURGICALLY CLOSED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE SEQUELA. THE PUNCTURE SITE WAS ALSO DESCRIBED AS MILDLY CALCIFIED AND IT HAD BEEN PREVIOUSLY ACCESSED. THE EVENT PROLONGED THE PATIENT'S HOSPITALIZATION, FOR 1 NIGHT. A 7FR. SHEATH WAS USED DURING THE VESSEL CLOSURE PROCEDURE. THE PHYSICIAN IS 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 060026H

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R SHEATH: 7F. OTHER: HEPARIN.