BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2233568 · Received September 2, 2011

    Report

    Report Number
    2024168-2011-06137
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROGLIDE DEVICE WAS NOT RETURNED FOR ANALYSIS, WHICH MAY HAVE ASSISTED THE INVESTIGATION OF THE EVENT. CONTINUED BLEEDING AFTER DEVICE DEPLOYMENT CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO: MANUFACTURING, USER TECHNIQUE AND PATIENT ANATOMICAL CONDITIONS. CLOSURE OF A 12 FR SHEATH SIZE ACCESS SITE WAS ATTEMPTED USING THIS DEVICE. THE PROGLIDE INSTRUCTIONS FOR USE (IFU) INDICATE THE DEVICE IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE CATHERIZATION PROCEDURES USING 5F TO 8F SHEATHS. THE SIZE OF THE ARTERIOTOMY WAS LIKELY TO HAVE PLAYED A ROLE FOR THE CONTINUED BLEEDING AFTER REPORTED UNEVENTFUL DEVICE DEPLOYMENT. REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FOR HEMOSTASIS NOT ACHIEVED. THE PROGLIDE DEVICES ARE VISUALLY TESTED DURING MANUFACTURING AND A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. BASED ON THE REVIEW OF THE DEVICE HISTORY RECORD, THE COMPLAINT HANDLING DATABASE, EVENT INFORMATION AND MANUFACTURING TESTING/INSPECTION CRITERIA FOR THIS LOT, A PRODUCT QUALITY DEFICIENCY WAS NOT DETECTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. INDICATION FOR USE (DO NOT ATTEMPT TO CLOSE CFA ACCESS SITES GREATER THAN 8 FR SHEATHS). THE PROGLIDE DEVICE IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE CRATERIZATION PROCEDURES USING 5F TO 8F SHEATHS. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED PRE-CLOSURE OF A NON-CALCIFIED RIGHT COMMON FEMORAL ARTERY (RCFA) PRIOR TO AN INTERVENTIONAL PROCEDURE TO TREAT COARCTATION OF THE AORTA USING A PROGLIDE DEVICE. REPORTEDLY, THE PROGLIDE WAS PRE-DEPLOYED, AND WHEN THE PHYSICIAN WAS READY TO CLOSE THE ARTERIOTOMY HE FORGOT WHICH END OF THE SUTURE IS THE RAIL. HE REMINDED HIMSELF OF THE CORRECT PROCEDURE FROM THE INTERNET AND PROCEEDED TO CLOSE THE PUNCTURE SITE. HOWEVER, HE WAS UNABLE TO ACHIEVE A DRY CLOSURE, AS BLEEDING WAS STILL OBSERVED, MANUAL ARTERIAL COMPRESSION WAS APPLIED FOR 20 MIN POST-SUTURE DEPLOYMENT TO ACHIEVE HEMOSTASIS. THE SUTURE WAS LEFT IN PLACE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY TO THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT. THE PROGLIDE WAS PRE-DEPLOYED USING A 6 FR. SHEATH AND THE PHYSICIAN UPGRADED TO 8 FR SHEATH, 10FR SHEATH AND TO 12FR SHEATH TO PERFORM THE INDEX PROCEDURE. THE PHYSICIAN IS TRAINED AND HAS RECENTLY BEEN CERTIFIED 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 060236H

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention SHEATH: TERUMO: 6FR, 8FR, 10FR, 12FR