BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2117423 · Received June 8, 2011

    Report

    Report Number
    2024168-2011-04025
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 17, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 OTHER PROGLIDE DEVICE IS BEING REPORTED UNDER SEPARATE MEDWATCH REPORT NUMBER. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). WITHOUT THE PRODUCT TO EXAMINE, NO DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE REPORTED INCIDENT. IT SHOULD BE NOTED THAT THE REPORTED USE OF POSITIONING OF THE PROGLIDE DEVICE IN A IN A VERY STEEP ANGLE IS NOT CONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU). THE IFU, 100-0867, ON PAGE 8 UNDER SMC DEVICE PLACEMENT STATES: 4. CONTINUE TO ADVANCE THE DEVICE JUST UNTIL A CONTINUOUS DRIP OF BLOOD IS EVIDENT FROM THE MARKER LUMEN. POSITION THE DEVICE AT A 45-DEGREE ANGLE. THEREFORE, THE CONTRIBUTING FACTOR TO THE EXPERIENCED EVENT IS DEVIATING FROM THE IFU. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS NOT PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE LOT NUMBER WAS NOT REPORTED. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. BASED ON THE INFORMATION PROVIDED AND THE INSPECTION CRITERIA THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT A USER FACILITY MEDWATCH REPORT WAS RECEIVED STATING "THE PATIENT HAD A STENT PROCEDURE PERFORMED (RIGHT SIDE) IN THE CATH LAB AND REPORTEDLY HAD A FAILURE WITH A CLOSURE DEVICE RESULTING IN A RUPTURE OF THE ARTERY. THE PATIENT STARTED BLEEDING AND THE DOCTOR PLACED A SHEATH IN THE LEFT GROIN AND ATTEMPTED TO TAMPONADE THE ARTERY WITH A BALLOON CROSSED OVER THE AORTIC BIFURCATION. THIS DID NOT HELP. A FEM-STOP DEVICE WAS APPLIED AND THE BLEEDING SLOWED. A HEMATOMA WAS FORMING UNDER THE FEM-STOP AND MANUAL PRESSURE WAS APPLIED. DOPAMINE WAS TITRATED UP AND THE CARDIOLOGIST WAS CALLED. THE PATIENT WAS TAKEN TO THE OR FOR AN EMERGENCY REPAIR OF THE FEMORAL ARTERY."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECHNICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE (HEART CATHETERIZATION). REPORTEDLY, THE KNOT COULD NOT BE ADVANCED AND THE SUTURE WAS REMOVED. A SECOND PROGLIDE WAS USED WITH THE SAME RESULTS. HEMOSTASIS WAS THOUGHT TO HAVE BEEN ACHIEVED USING MANUAL COMPRESSION. THERE WAS NO REPORTED HEMATOMA, BUT THERE WAS SOME BRUISING. THE SHEATH WAS NOTED TO BE AT A VERY STEEP ANGLE, NOT AT A 45-DEGREE ANGLE PER THE INSTRUCTION FOR USE. THE PATIENT WAS MOVED TO THEIR BED; HOWEVER, BLEEDING FROM THE ACCESS SITE OCCURRED. THE PATIENT WAS TAKEN TO THE LAB AND PATIENT'S OTHER COMMON FEMORAL ARTERY WAS ACCESSED AND FILMS CONFIRMED BLEEDING OF THE CONTRALATERAL ARTERY. THE PHYSICIAN ADVANCED A BALLOON TO OCCLUDE THE ARTERIAL SITE AND TEMPORARILY SEALED THE LEAK. THE PATIENT WAS RETURNED TO THEIR ROOM; HOWEVER, BLEEDING BEGAN AGAIN. THE PATIENT WAS TAKEN TO SURGERY AND A "SMALL TEAR" IN THE ARTERY WAS FOUND. THE VESSEL WAS SURGICALLY REPAIRED AND HEMOSTASIS WAS ACHIEVED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention PLAVIX AND HEPARIN