BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3043047 · Received April 9, 2013

    Report

    Report Number
    2024168-2013-02103
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 20, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT WAS CONFIRMED. THE ANALYSIS OBSERVED A POSTERIOR FOOT WAS DEPLOYED DURING DEVICE REMOVAL WHICH RESULTED IN THE REPORTED EXPERIENCE. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, 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. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PROGLIDE DEVICE WAS DEPLOYED SUCCESSFULLY; HOWEVER, WHEN THE DEVICE WAS BEING REMOVED FROM THE RIGHT COMMON FEMORAL ARTERY, AFTER A RIGHT CORONARY INTERVENTIONAL PROCEDURE, A PIECE OF INTIMA WAS ATTACHED RESULTING IN UNCONTROLLED BLEEDING. THE ARTERIOTOMY WAS 6 F AND THE PHYSICIAN UPSIZED THE SHEATH TO A 7 F IN AN ATTEMPT TO CONTROL THE BLEEDING; HOWEVER, WAS UNSUCCESSFUL. THE PATIENT RECEIVED ANGIOMAX DURING THE PROCEDURE. A VASCULAR SURGEON WAS CALLED TO PERFORM A CUT-DOWN AND REPAIR THE ARTERY. A RETROPERITONEAL HEMATOMA (9 CM) WAS FOUND DURING THE REPAIR PROCEDURE. APPROXIMATELY, A LITER OF BLOOD FROM THE RETROPERITONEAL HEMATOMA WAS REMOVED FROM STOMACH AREA. THE FOLLOWING MORNING THE PATIENT WAS HYPOTENSIVE, BUT STABLE. THERE WAS NO RESISTANCE FELT WHEN THE PROGLIDE DEVICE WAS REMOVED FROM THE ARTERIOTOMY. THERE WAS A SIGNIFICANT IMPACT TO THE PATIENT BECAUSE OF THE SURGICAL REPAIR OF THE RIGHT COMMON FEMORAL ARTERY. BOTH THE PHYSICIAN WHO DEPLOYED THE PROGLIDE DEVICE AND THE VASCULAR SURGEON WHO REPAIRED THE ARTERY ARE TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH, ADDITIONAL INFORMATION WAS RECEIVED: UPON REMOVAL OF THE PROGLIDE DEVICE, INTIMA WAS ATTACHED TO THE TIP OF THE PROGLIDE CATHETER. THERE WAS NO POST PROCESS MANIPULATION OF THE PROGLIDE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147211 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30107J1

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention SHEATH: 6F ANGIOMAX