BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2181639 · Received July 27, 2011

    Report

    Report Number
    2024168-2011-05326
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THAT THE PLUNGER AND ANTERIOR NEEDLE WERE NOT RETURNED. THE DEVICE WAS RECEIVED IN A TOTALLY DISASSEMBLED CONDITION, WHICH IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE DEVICE WAS SURGICALLY REMOVED. THE GUIDE WAS COMPLETELY DETACHED AT THE DISTAL END OF THE GUIDE TUBE. THE DISTAL END OF THE GUIDE TUBE WHERE THE GUIDE BROKE WAS SEVERELY BENT. CONTRIBUTING FACTORS FOR BROKEN GUIDE AND BENT GUIDE TUBE INCLUDE, BUT ARE NOT LIMITED TO: MANUFACTURING DEFICIENCIES, CHALLENGING ANATOMICAL CONDITIONS, AND INCORRECT DEPLOYMENT TECHNIQUE. AS REPORTED, THE ACCESS SITE AND ARTERY WERE HEAVILY CALCIFIED WHICH COULD HAVE CAUSED THE GUIDE TO DETACH AT THE GUIDE TUBE IF EXCESSIVE DOWNWARD PRESSURE WAS APPLIED WHEN INTRODUCING THE DEVICE INTO THE PATIENT ANATOMY. THE GUIDE COULD ALSO BREAK IF THE DEVICE WAS INTRODUCED INTO THE ANATOMY AT AN ANGLE GREATER THAN 45 DEGREES; HOWEVER, THIS COULD NOT BE CONFIRMED. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR THE GUIDE BREAK IS INSERTING THE DEVICE AGAINST RESISTANCE INTO THE PATIENT CHALLENGING ANATOMY, AS REPORTED. THE INSTRUCTIONS FOR USE (IFU), UNDER THE PRECAUTIONS SECTION, STATES: DO NOT ADVANCE OR WITHDRAW THE PERCLOSE PROGLIDE DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THAT RESISTANCE HAS BEEN DETERMINED. EXCESSIVE FORCE USED TO ADVANCE OR TORQUE THE PERCLOSE PROGLIDE 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. INSPECTION OF THE RETURNED DEVICE ALSO REVEALED A POSTERIOR CUFF MISS, AS EVIDENCED BY THE POSTERIOR CUFF REMAINING IN THE FOOT POCKET. THE POSTERIOR NEEDLE TIP WAS RELEASED FROM THE SHANK BUT DID NOT ENGAGE WITH THE POSTERIOR CUFF AND REMAINED UNDISTURBED. THIS IS CONSISTENT WITH THE POSTERIOR NEEDLE BEING DEFLECTED AWAY FROM THE POSTERIOR FOOT DURING NEEDLE DEPLOYMENT, INSTEAD OF ENGAGED WITH THE POSTERIOR CUFF INSIDE THE POSTERIOR FOOT POCKET, AS INTENDED. BECAUSE THE POSTERIOR NEEDLE DID NOT ENGAGE WITH THE POSTERIOR CUFF, THE CUFF WAS NOT EJECTED FROM THE FOOT. WHEN THE PLUNGER WAS REMOVED FROM THE DEVICE, THE LINK WAS HELD ON ONE END BY THE POSTERIOR CUFF IN THE FOOT POCKET WHILE BEING PULLED ON THE OTHER END BY THE WITHDRAWAL OF THE PLUNGER. THIS RESULTED IN THE ANTERIOR CUFF DETACHING FROM THE NEEDLE AS INDICATED BY FLATTENED ANTERIOR CUFF TABS. CONTRIBUTING FACTORS FOR THE POSTERIOR CUFF MISS WHICH SUBSEQUENTLY RESULTED IN THE ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT INCLUDE, BUT ARE NOT LIMITED TO: MANUFACTURING, CHALLENGING ANATOMICAL CONDITIONS, AND INCORRECT DEPLOYMENT TECHNIQUE. AS REPORTED, THE ACCESS SITE AND ARTERY WERE HEAVILY CALCIFIED WHICH COULD HAVE CAUSED THE POSTERIOR NEEDLE TO DEFLECT AND RESULT IN THE POSTERIOR CUFF MISS. THE GUIDE BREAKAGE COULD HAVE ALSO CAUSED THE NEEDLE DEFLECTION. BASED ON THE REPORTED INFORMATION AND NEEDLE TRAJECTORY TESTING DURING MANUFACTURING, THE PROBABLE CAUSE FOR THE POSTERIOR CUFF MISS AND SUBSEQUENT ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT IS INCORRECT DEPLOYMENT TECHNIQUE AS THE DEVICE WAS INTRODUCED INTO CHALLENGING ANATOMY AGAINST RESISTANCE WHICH COULD HAVE CAUSED THE POSTERIOR NEEDLE TO DEFLECT DURING THE PLUNGER DEPLOYMENT. BECAUSE THE GUIDE HAD BEEN DETACHED, THE FOOT COULD NOT BE RETRACTED TO REMOVE THE DEVICE, RESULTING IN DIFFICULT DEVICE REMOVAL THAT REQUIRED SURGICAL INTERVENTION. HOWEVER, IT WAS REPORTED THAT THE FOOT WAS ABLE TO BE RETRACTED WHICH IS INCONSISTENT WITH OUR INVESTIGATION FINDINGS. A POSSIBLE CAUSE FOR THE REPORTED INABILITY TO RETRACT THE PLUNGER FROM THE DEVICE IS CLOSING THE LEVER TO RETRACT THE FOOT PRIOR TO REMOVING THE PLUNGER FROM THE DEVICE, RESULTING IN DAMAGED NEEDLE FOLLOWER AT THE PROXIMAL END OF THE PLUNGER. THIS IS AN INCORRECT DEVICE DEPLOYMENT SEQUENCE PER THE IFU; HOWEVER, BECAUSE THE PLUNGER WAS NOT RETURNED, THIS COULD NOT BE CONFIRMED. EVERY GUIDE AND GUIDE TUBE IS INSPECTED FOR PROPER ASSEMBLY DURING MANUFACTURING. ALSO, THE NEEDLE TRAJECTORY OF EVERY DEVICE IS VERIFIED TWICE DURING MANUFACTURING. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS FOR THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT AND ITS INVESTIGATION FINDINGS. A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT REVEALED NO OTHER INCIDENTS WITH REPORTED DIFFICULTY RETRACTING THE PLUNGER AND REMOVING THE DEVICE.

    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 HAS 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 WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT ADDITIONAL INFORMATION RECEIVED INDICATES: RESISTANCE WAS FELT DURING THE INSERTION OF THE PROGLIDE DEVICE INTO THE PATIENT'S ANATOMY. AFTER SURGICAL REMOVAL IT WAS OBSERVED THAT THE DEVICE WAS ALL TWISTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF A HEAVILY CALCIFIED LEFT COMMON FEMORAL ARTERY (LCFA) AFTER A REPAIR OF A LEFT INTERNAL ILIAC ANEURYSM PROCEDURE USING A PROGLIDE DEVICE. REPORTEDLY, DURING THE PLUNGER REMOVAL STEP, THE PLUNGER COULD NOT BE RETRACTED AND THE DEVICE GOT STUCK IN THE PATIENT'S ANATOMY. THE PATIENT WAS TAKEN TO THE OPERATING ROOM, GENERAL ANESTHESIA ADMINISTERED, A SURGICAL CUT DOWN WAS PERFORMED AND THE LCFA WAS REPAIRED SURGICALLY ACHIEVING HEMOSTASIS. THE PHYSICIAN BELIEVES THAT THE CLOSURE DEVICE GOT STUCK DUE TO THE HIGHLY CALCIFIED PLAQUE ON THE ANTERIOR WALL OF THE LCFA. IT WAS ALSO INDICATED THAT THE ACCESS SITE WAS ALSO HIGHLY CALCIFIED. THERE WERE NO ADVERSE PATIENT SEQUELAE. A 7FR SHEATH WAS USED FOR THE INDEX PROCEDURE AND VESSEL CLOSURE ATTEMPT. THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE. THIS EVENT PROLONGED THE PATIENT'S HOSPITALIZATION. 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 020316H

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R SHEATH: 7 FR. OTHER: HEPARIN.