BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2151951 · Received July 7, 2011

    Report

    Report Number
    2024168-2011-04788
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    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 CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER PROGLIDE DEVICE IS BEING SUBMITTED ON A SEPARATE MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). A THOROUGH ANALYSIS ON THE PRODUCT COULD NOT BE PERFORMED BECAUSE IT WAS NOT RETURNED FOR INVESTIGATION. WITHOUT THE PRODUCT TO EXAMINE, NO DETERMINATION CAN BE MADE AS TO THE CONTRIBUTING FACTORS THAT CAUSED THE REPORTED DISCREPANCY. A CUFF-MISS CAN BE INFLUENCED BY MANY FACTORS INCLUDING, BUT IS NOT LIMITED TO, MANUFACTURING, FAILURE TO POSITION AND MAINTAIN THE DEVICE AT A 45 DEGREE ANGLE THROUGHOUT DEPLOYMENT, ROTATING THE DEVICE AT ANY POINT DURING PLUNGER/NEEDLE DEPLOYMENT, DEPLOYMENT IN A CHALLENGING ANATOMY, AGGRESSIVELY DEPLOYING OR REMOVING THE PLUNGER AND/OR INADEQUATE POSITIONING OF THE FOOT AGAINST THE ARTERIAL WALL. WHETHER THESE CONDITIONS PLAYED A ROLE IN THE EXPERIENCED EVENT CANNOT BE VERIFIED. TO ENSURE THIS TYPE OF EXPERIENCE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED DURING MANUFACTURE OF THE DEVICE. IN ADDITION, A SAMPLING OF FINISHED DEVICES ARE TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS RELATED TO THIS REPORTED EVENT. BASED ON THE INFORMATION AVAILABLE, THE INSPECTION CRITERIA AND THE REVIEW OF THE LOT HISTORY RECORD, THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN PLACED THE PROGLIDE SUTURE USING THE PRE-CLOSE TECHNIQUE THROUGH A 6FR SHEATH IN A COMMON FEMORAL ARTERY PRIOR TO AN INTERVENTIONAL PROCEDURE (ABDOMINAL AORTIC ANEURYSM REPAIR). REPORTEDLY, PRIOR TO PROCEDURE A PROGLIDE SUTURE WAS PLACED SUCCESSFULLY USING THE PRE-CLOSE TECHNIQUE. A SECOND PROGLIDE WAS ALSO BEING USED; HOWEVER, WHEN THE PROGLIDE WAS USED, A CUFF MISS OCCURRED. THE SECOND PROGLIDE WAS REMOVED AND A THIRD PROGLIDE WAS USED WITH THE SAME RESULTS. THE TWO PROGLIDE DEVICES WERE TO CLOSE AN 18FR PUNCTURE. AFTER THE ABDOMINAL AORTIC ANEURYSM REPAIR, EMBOLIZATION OF THE INTERNAL ILIAC ARTERY DUE TO AN ENDOLEAK (CLASS 1B) REPAIR WERE COMPLETED AND THE ARTERIOTOMY CLOSURE WAS COMPLETED WITH THE FIRST PRE-PLACED PROGLIDE SUTURE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO CLINICALLY SIGNIFICANT DELAY IN THE INTERVENTIONAL PROCEDURE WAS REPORTED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION.

    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 020316H

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention SHEATH: 6FR (11CM), 18FR