BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3112428 · Received May 14, 2013

    Report

    Report Number
    2024168-2013-03038
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 2, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE BODY OF THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED CUFF MISS WAS UNABLE TO BE CONFIRMED, BECAUSE KEY DEVICE COMPONENTS WERE NOT RETURNED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE COMPONENT, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE PHYSICIAN WAS REPORTEDLY NOT TRAINED IN THE USE OF THE PROGLIDE DEVICE. PER THE INSTRUCTIONS FOR USE (IFU) UNDER CAUTION WHICH STATES; THIS DEVICE SHOULD ONLY BE USED BY PHYSICIANS (OR ALLIED HEALTHCARE PROFESSIONALS, AUTHORIZED BY, OR UNDER THE DIRECTION OF, SUCH PHYSICIANS) WHO ARE TRAINED IN DIAGNOSTIC AND THERAPEUTIC CATHETERIZATION PROCEDURES AND WHO HAVE BEEN TRAINED BY AN AUTHORIZED REPRESENTATIVE OF ABBOTT VASCULAR. ALSO, STATED IN THE IFU UNDER THE SPECIAL PATIENT POPULATIONS, THE SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED, IN PATIENT POPULATIONS: PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. THE EVALUATION INDICATED THAT USER TECHNIQUE HAD INFLUENCED THE REPORTED EVENT, THEREFORE, THE CAUSE IS DUE TO USER ERROR FOR FAILURE TO FOLLOW THE IFU.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4) - OPERATOR NOT TRAINED. PER THE INSTRUCTIONS FOR USE, UNDER CAUTION - THIS DEVICE SHOULD ONLY BE USED BY PHYSICIANS (OR OTHER HEALTHCARE PROFESSIONALS AUTHORIZED BY OR UNDER THE DIRECTION OF SUCH PHYSICIANS) WHO ARE TRAINED IN DIAGNOSTIC AND THERAPEUTIC CATHETERIZATION PROCEDURES AND WHO HAVE BEEN TRAINED BY AN AUTHORIZED REPRESENTATIVE OF ABBOTT VASCULAR. IT WAS REPORTED THAT THE COMMON FEMORAL ARTERY WAS SLIGHTLY (MILDLY) CALCIFIED. PER THE INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. 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. THE OTHER FOUR PROGLIDE DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WAS ATTEMPTED USING TWO PROGLIDE DEVICES IN THE COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. THE ARTERIOTOMY WAS A 6F AND SLIGHTLY (MILDLY) CALCIFIED. REPORTEDLY, TWO PROGLIDE DEVICES WERE PLACED USING THE PRECLOSE TECHNIQUE. WHEN THE PLUNGER WAS RETRACTED A CUFF MISS OCCURRED WITH BOTH PROGLIDE DEVICES. BOTH PROGLIDE DEVICES WERE REMOVED AND TWO ADDITIONAL PROGLIDE DEVICES WERE USED AND WHEN THE PLUNGER WAS RETRACTED FROM ONE OF THE PROGLIDE DEVICES A CUFF MISS OCCURRED. THE DEVICE WAS REMOVED AND ANOTHER PROGLIDE DEVICE WAS USED. WHEN THE PLUNGER WAS RETRACTED ON BOTH OF THE PROGLIDE DEVICES THAT HAD BEEN PLACED USING THE PRECLOSE TECHNIQUE, CUFF MISSES OCCURRED. THE TWO DEVICES WERE REMOVED AND THE SHEATH WAS UPSIZED TO A 14F. THE AAA PROCEDURE WAS SUCCESSFULLY PERFORMED AND A CUT-DOWN WAS PERFORMED TO ACHIEVE HEMOSTASIS. THE PATIENT IS REPORTED TO BE DOING FINE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. THE PHYSICIAN IS REPORTED NOT TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE OR PRECLOSE TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213588 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 21020J1

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention SHEATH: 6F, 14F, HEPARIN