BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2152603 · Received July 7, 2011

    Report

    Report Number
    2024168-2011-04810
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 FOUND THAT THE ANTERIOR CUFF AND LINK WERE ENGAGED TO ANTERIOR NEEDLE TIP. THE MONOFILAMENT, POSTERIOR CUFF AND NEEDLE TIP WERE NOT RETURNED WITH THE DEVICE. BASED ON THE INVESTIGATION FINDINGS, THE LINK WAS PULLED FROM THE POSTERIOR CUFF. THE LINK CONNECTS THE ANTERIOR NEEDLE TO THE SUTURE; IF THE LINK IS PULLED FROM THE CUFF, THE SUTURE WILL NOT BE PRESENT DURING PLUNGER WITHDRAWAL AND CAN APPEAR VERY SIMILAR TO A CUFF MISS. DURING NEEDLE DEPLOYMENT (STEP #3) THE SUTURE IS HARVESTED AND PULLED THROUGH THE SUTURE BEARING AND ANTERIOR NEEDLE GUIDE; RESISTANCE AT THIS POINT OF DEPLOYMENT CAN CAUSE THE LINK TO DETACH OR BREAK. A LINK PULLED CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO MANUFACTURING, EXCESSIVE TENSION DURING PLUNGER RETRACTION BY AGGRESSIVELY REMOVING THE PLUNGER AND EXCESSIVE FORCE CAN BE CAUSED BY HIGH FRICTION AGAINST THE SUTURE DUE TO CHALLENGING ANATOMIES (E.G. HEAVY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.). IT COULD NOT BE DETERMINED IF THE REPORTED ATTEMPT TO DEPLOY THE PROGLIDE DEVICE IN A MILDLY CALCIFIED RIGHT COMMON FEMORAL ARTERY CONTRIBUTED TO THE REPORTED EVENT. THERE WAS NO PRODUCT QUALITY DEFICIENCY DETECTED THAT WOULD CONTRIBUTE TO THIS EVENT; THEREFORE, NO PROBABLE CAUSE COULD BE DETERMINED FOR THE LINK PULLED FROM THE CUFF. A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF A MILDLY CALCIFIED RIGHT COMMON FEMORAL ARTERY USING A PERCLOSE PROGLIDE DEVICE AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE PROFICIENT IN THE USE OF THE PROGLIDE DEVICE. NO CLINICALLY SIGNIFICANT DELAY IN THE DIAGNOSTIC PROCEDURE WAS REPORTED. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 010406H

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention SHEATH: 6F