BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3041385 · Received April 8, 2013

    Report

    Report Number
    2024168-2013-02083
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER PERCLOSE PROGLIDE DEVICES, REFERENCED, ARE BEING FILED UNDER SEPARATE MEDWATCH MANUFACTURER REPORT NUMBERS. (B)(4) - FAILURE TO FOLLOW STEPS/INSTRUCTIONS. DESPITE NOT ACHIEVING PULSATILE ARTERIAL MARKING, THE PROGLIDE DEVICE WAS DEPLOYED. THE PROGLIDE DEVICE INSTRUCTIONS FOR USE STATES UNDER SMC DEVICE PLACEMENT TO 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. DEPLOY THE FOOT BY LIFTING THE LEVER (MARKED #1) ON TOP OF THE HANDLE. DO NOT DEPLOY THE FOOT UNLESS A CONTINUOUS DRIP OF BLOOD IS EVIDENT FROM THE MARKER LUMEN. REPORTEDLY THE LEFT COMMON FEMORAL ARTERY WAS MILDLY CALCIFIED. THE INSTRUCTIONS FOR USE STATE UNDER SPECIAL PATIENT POPULATIONS THAT THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE SMC DEVICES HAVE NOT BEEN ESTABLISHED IN PATIENT POPULATIONS WITH FEMORAL ARTERY CALCIUM, WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. THE PATIENT WAS REPORTED TO BE MORBIDLY OBESE WEIGHTING (B)(6) WITH A HEIGHT OF (B)(6). THE CALCULATED BODY MASS INDEX IS (B)(6). PER THE SPECIAL PATIENT POPULATIONS SECTION OF THE PERCLOSE PROGLIDE DEVICE INSTRUCTIONS FOR USE THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE DEVICE HAS NOT BEEN ESTABLISHED IN THE PATIENT POPULATIONS WHO ARE MORBIDLY OBESE WITH A BODY MASS INDEX GREATER THAN (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE WAS DISCARDED AND IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. FAILURE TO FOLLOW STEPS/INSTRUCTIONS. DESPITE NOT ACHIEVING PULSATILE ARTERIAL MARKING, THE PROGLIDE DEVICE WAS DEPLOYED. THE PROGLIDE DEVICE INSTRUCTIONS FOR USE STATES UNDER SMC DEVICE PLACEMENT TO 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. DEPLOY THE FOOT BY LIFTING THE LEVER (MARKED #1) ON TOP OF THE HANDLE. DO NOT DEPLOY THE FOOT UNLESS A CONTINUOUS DRIP OF BLOOD IS EVIDENT FROM THE MARKER LUMEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, PRE-CLOSE PLACEMENT OF THE SUTURES WAS ACHIEVED OF A MILDLY CALCIFIED LEFT FEMORAL ARTERY THROUGH A 6-FRENCH SIZED ACCESS SITE USING THREE PROGLIDE DEVICES. DESPITE NOT ACHIEVING PULSATILE ARTERIAL MARKING, THE SUTURES FROM THREE PROGLIDE DEVICES WERE DEPLOYED. THE SUTURES WERE SET TO THE SIDE AND THE ACCESS SITE WAS UPSIZED TO 24-FRENCH. AFTER THE TAVI PROCEDURE, THE KNOTS OF THE THREE SUTURES WERE SEQUENTIALLY ADVANCED AND TIGHTENED, BUT BLEEDING CONTINUED. IN PREPARATION FOR SURGICAL INTERVENTION THE EFFECTS OF THE ANTICOAGULANT WAS REVERSED WITH PROTAMINE. EXPLORATORY SURGERY REVEALED THAT THE SUTURES GRABBED SUBCUTANEOUS TISSUE INSTEAD OF ARTERIAL TISSUE AND THERE WAS NO ARTERIAL CLOSURE. THE ACCESS SITE WAS SURGICALLY SUTURED TO ACHIEVE HEMOSTASIS. HOSPITALIZATION WAS EXTENDED DUE TO THE DEVICE ISSUES. THE OPERATOR WAS REPORTED TO BE TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THERE WAS A REPORTEDLY SIGNIFICANT CLINICAL DELAY IN THE VESSEL CLOSURE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143489 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R SHEATHS: 6-FRENCH, 24-FRENCH HEPARIN