BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2802153 · Received October 23, 2012

    Report

    Report Number
    2024168-2012-06707
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 10, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE.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). LOT NUMBER CORRECTED FROM 20712J1 TO 20721J1. FORCEFUL DEVICE REMOVAL. THE PROGLIDE INSTRUCTIONS FOR USE INDICATE: DO NOT ADVANCE OR WITHDRAW THE DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THAT RESISTANCE HAS BEEN DETERMINED. EXCESSIVE FORCE USED TO ADVANCE OR TORQUE THE DEVICE SHOULD BE AVOIDED, AS THIS MAY LEAD TO SIGNIFICANT VESSEL DAMAGE AND/OR BREAKAGE OF THE DEVICE, WHICH MAY NECESSITATE INTERVENTION AND/OR SURGICAL REMOVAL OF THE DEVICE AND VESSEL REPAIR. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT OF FOOT WOULD NOT RETRACT WAS NOT CONFIRMED. THE DEVICE WAS RECEIVED WITH THE FOOT DETACHED AND DAMAGE AT THE AREA WHERE THE FOOT IS POSITIONED AND COMPONENTS THAT INTERACT WITH THE FOOT WERE SEVERED. FUNCTIONAL TESTING CONFIRMED THE MECHANISM TO RETRACT THE FOOT INSIDE THE SHEATH ACTUATED ACCORDINGLY. REPORTEDLY, THE VESSEL WAS MILDLY CALCIFIED AND CALCIUM HAS THE POTENTIAL TO INTERFERE WITH FOOT PARKING AND RESULT IN THE REPORTED USE OF FORCE. BASED ON THE REPORTED INFORMATION AND THE INVESTIGATION FINDINGS, THE MOST LIKELY CAUSE FOR THE REPORTED EVENT WAS DETERMINED TO BE RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. 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

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION RECEIVED INDICATES: THE FOOT WOULD NOT RETRACT AND THE DEVICE WAS PULLED OUT FORCEFULLY AND TORE THE ARTERY. THE PHYSICIAN WAS NOT SURE AS TO WHY THE FOOT WOULD NOT RETRACT; HOWEVER, THERE WAS A SURGEON ON THE CASE AND THEY CONVERTED TO A CUT DOWN. A PATCH WAS USED TO REPAIR THE TEAR IN THE ARTERY AND EVERYTHING WAS FINE FROM THAT POINT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT OF THE PROGLIDE DEVICE WAS ATTEMPTED IN THE RIGHT COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE. THE ARTERIOTOMY WAS 6 FR AND THE VESSEL WAS MILDLY CALCIFIED. REPORTEDLY, A CUFF MISS OCCURRED. IT WAS INDICATED THAT THE CUFF MISS WAS PROBABLY CAUSED BY CALCIUM. A DECISION WAS MADE TO SURGICALLY CLOSE THE VESSEL AT THE END OF THE INDEX PROCEDURE VIA CUT DOWN. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED 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 20721J1

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention SHEATH: 6 FR.