BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2180331 · Received July 27, 2011

    Report

    Report Number
    2024168-2011-05275
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 1, 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). IT WAS REPORTED THAT A NEEDLE-TO-CUFF MISS OCCURRED. WHEN THE NEEDLE PLUNGER WAS REMOVED, NO SUTURE WAS ATTACHED TO THE NEEDLES. A NEEDLE-TO-CUFF MISS CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING, USER TECHNIQUE, SUCH AS, FAILURE TO POSITION AND MAINTAIN THE DEVICE AT A 45 DEGREE ANGLE THROUGHOUT DEPLOYMENT, ROTATING THE DEVICE AT ANY POINT DURING PLUNGER/NEEDLE DEPLOYMENT, AGGRESSIVELY DEPLOYING OR REMOVING THE NEEDLE PLUNGER AND/OR INADEQUATE POSITIONING OF THE FOOT AGAINST THE ARTERIAL WALL. HOWEVER, NO INFORMATION IN REGARDS TO THE USER TECHNIQUE WAS PROVIDED. PATIENT ANATOMY (E.G. HEAVY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.) CAN ALSO CAUSE THE REPORTED EVENT, BUT NO INFORMATION IN THIS REGARD WAS REPORTED. HOWEVER, AN ANGIOGRAM DID NOT REVEAL ANY PRESENCE OF CALCIFIED PLAQUE, TORTUOSITY, OR SCARRING AT THE ACCESS SITE AND AT THE TARGET GROIN. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY RELEVANT NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. A QUERY OF THE VIPER COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FOR NEEDLE-TO-CUFF MISS FROM THIS LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, WHICH MAY HAVE AIDED IN THE INVESTIGATION; ADDITIONALLY, THERE WAS LIMITED REPORTED INFORMATION AND A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED COMPLAINT. TO ENSURE THIS TYPE OF EXPERIENCE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED TWICE DURING MANUFACTURE OF THE DEVICE. IN ADDITION, A SAMPLING OF FINISHED DEVICES IS ALSO DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. IN THIS CASE NO INFORMATION CONCERNING USER TECHNIQUE WAS PROVIDED AND BASED ON THE INSPECTION CRITERIA, FINISHED DEVICE LOT HISTORY RECORDS AND THE AVAILABLE INFORMATION, NO PRODUCT QUALITY DEFICIENCY WAS NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. DEVICE #1 PROGLIDE IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DIAGNOSTIC PERCUTANEOUS NEUROLOGICAL CATHETERIZATION THROUGH A 6F PROCEDURAL SHEATH, ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, A NEEDLE-TO-CUFF MISS OCCURRED. WHEN THE NEEDLE PLUNGER WAS REMOVED FROM THE BODY OF THE DEVICE, THERE WAS NO SUTURE ATTACHED TO THE NEEDLE. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND A SECOND PROGLIDE DEVICE WAS ATTEMPTED, BUT WITH THE SAME RESULTS, A NEEDLE-TO-CUFF MISS OCCURRED. THE SECOND DEVICE WAS REMOVED OVER A GUIDE WIRE AND A NON-ABBOTT VESSEL CLOSURE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTEDLY IN TRAINING IN THE USE OF THE PROGLIDE DEVICE. 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 040356H

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention PROCEDURAL SHEATH 6F