BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3250986 · Received July 29, 2013

    Report

    Report Number
    2024168-2013-04728
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 12, 2013
    Report Date
    July 12, 2013
    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). IT IS INDICATED THAT THE DEVICE WAS DISCARDED AND IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. REPORTEDLY, DURING EMERGENT EXPLORATORY SURGERY A BACK WALL PUNCTURE WAS FOUND. THE INSTRUCTIONS FOR USE STATES UNDER WARNINGS NOT USE THE PERCLOSE PROGLIDE SMC SYSTEM IF THE PUNCTURE IS THROUGH THE POSTERIOR WALL OR IF THERE ARE MULTIPLE PUNCTURES, SINCE SUCH PUNCTURES MAY RESULT IN A HEMATOMA OR RETROPERITONEAL BLEED. THE IFU ALSO STATES UNDER PRECAUTIONS TO USE A SINGLE WALL PUNCTURE TECHNIQUE. DO NOT PUNCTURE THE POSTERIOR WALL OF THE ARTERY. THE IFU ADDITIONALLY STATES UNDER ARTERIAL SITE AND PUNCTURE CONSIDERATIONS TO PUNCTURE THE ANTERIOR WALL OF THE COMMON FEMORAL ARTERY AT AN ANGLE OF APPROXIMATELY 45 DEGREES. AVOID SIDE WALL OR POSTERIOR WALL FEMORAL ARTERY PUNCTURES. PRIOR TO DEPLOYMENT OF THE PERCLOSE PROGLIDE SMC DEVICE, PERFORM A FEMORAL ANGIOGRAM TO EVALUATE THE FEMORAL ARTERY SITE FOR VESSEL SIZE, CALCIUM DEPOSITS, TORTUOSITY, AND FOR DISEASE OR DISSECTIONS OF THE ARTERIAL WALL TO AVOID DEVICE CUFF MISSES (DEVICE NEEDLES NOT ENGAGING WITH THE CUFFS) AND/OR POSTERIOR WALL SUTURE PLACEMENT AND POSSIBLE LIGATION OF THE ANTERIOR AND POSTERIOR WALLS OF THE FEMORAL ARTERY. PERCUTANEOUS CANNULATION OF THE VESSEL WAS REPORTED TO BE A HIGH ABOVE THE MOST INFERIOR BORDER OF THE INFERIOR EPIGASTRIC ARTERY (IEA). THE PERCLOSE PROGLIDE INSTRUCTIONS FOR USE STATE UNDER SPECIAL PATIENT POPULATIONS THAT THE SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH ACCESS SITES ABOVE THE MOST INFERIOR BORDER OF THE INFERIOR EPIGASTRIC ARTERY (IEA) AND/OR ABOVE THE INGUINAL LIGAMENT BASED UPON BONY LANDMARKS. ADDITIONALLY, THE IFU STATES UNDER WARNING NOT TO USE THE PERCLOSE PROGLIDE SMC SYSTEM IF THE PUNCTURE SITE IS LOCATED ABOVE THE MOST INFERIOR BORDER OF THE INFERIOR EPIGASTRIC ARTERY (IEA) AND/OR ABOVE THE INGUINAL LIGAMENT BASED UPON BONY LANDMARKS, SINCE SUCH A PUNCTURE SITE MAY RESULT IN A RETROPERITONEAL HEMATOMA.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). PERCUTANEOUS CANNULATION OF THE VESSEL WAS REPORTEDLY PERFORMED PURPOSELY HIGH ABOVE THE MOST INFERIOR BORDER OF THE INFERIOR EPIGASTRIC ARTERY (IEA) AS THE PHYSICIAN INDICATED HE WANTED TO AVOID A RETROPERITONEAL BLEED. THE PERCLOSE PROGLIDE INSTRUCTIONS FOR USE STATE UNDER SPECIAL PATIENT POPULATIONS THAT THE SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH ACCESS SITES ABOVE THE MOST INFERIOR BORDER OF THE INFERIOR EPIGASTRIC ARTERY (IEA) AND/OR ABOVE THE INGUINAL LIGAMENT BASED UPON BONY LANDMARKS. ADDITIONALLY, THE IFU STATES UNDER WARNING NOT TO USE THE PERCLOSE PROGLIDE SMC SYSTEM IF THE PUNCTURE SITE IS LOCATED ABOVE THE MOST INFERIOR BORDER OF THE INFERIOR EPIGASTRIC ARTERY (IEA) AND/OR ABOVE THE INGUINAL LIGAMENT BASED UPON BONY LANDMARKS, SINCE SUCH A PUNCTURE SITE MAY RESULT IN A RETROPERITONEAL HEMATOMA. (B)(4). REPORTEDLY, DURING EMERGENT EXPLORATORY SURGERY IT WAS FOUND THAT THERE WAS A BACK WALL PUNCTURE. THE IFU STATES UNDER WARNINGS NOT USE THE PERCLOSE PROGLIDE SMC SYSTEM IF THE PUNCTURE IS THROUGH THE POSTERIOR WALL OR IF THERE ARE MULTIPLE PUNCTURES, SINCE SUCH PUNCTURES MAY RESULT IN A HEMATOMA OR RETROPERITONEAL BLEED. THE IFU ALSO STATES UNDER PRECAUTIONS TO USE A SINGLE WALL PUNCTURE TECHNIQUE. DO NOT PUNCTURE THE POSTERIOR WALL OF THE ARTERY. THE IFU ADDITIONALLY STATES UNDER ARTERIAL SITE AND PUNCTURE CONSIDERATIONS TO PUNCTURE THE ANTERIOR WALL OF THE COMMON FEMORAL ARTERY AT AN ANGLE OF APPROXIMATELY 45 DEGREES. AVOID SIDE WALL OR POSTERIOR WALL FEMORAL ARTERY PUNCTURES. PRIOR TO DEPLOYMENT OF THE PERCLOSE PROGLIDE SMC DEVICE, PERFORM A FEMORAL ANGIOGRAM TO EVALUATE THE FEMORAL ARTERY SITE FOR VESSEL SIZE, CALCIUM DEPOSITS, TORTUOSITY, AND FOR DISEASE OR DISSECTIONS OF THE ARTERIAL WALL TO AVOID DEVICE CUFF MISSES (DEVICE NEEDLES NOT ENGAGING WITH THE CUFFS) AND/OR POSTERIOR WALL SUTURE PLACEMENT AND POSSIBLE LIGATION OF THE ANTERIOR AND POSTERIOR WALLS OF THE FEMORAL ARTERY. THE RIGHT COMMON FEMORAL ARTERY WAS REPORTEDLY MILDLY CALCIFIED. THE PERCLOSE PROGLIDE INSTRUCTIONS FOR USE (IFU) STATE UNDER SPECIAL PATIENT POPULATIONS THAT THE SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM, WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. THE OTHER PERCLOSE PROGLIDE DEVICE, REFERENCED WAS FILED UNDER A SEPARATE MEDWATCH MANUFACTURER REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A PERIPHERAL ILIAC STENTING PROCEDURE, ARTERIOTOMY CLOSURE OF A MILDLY CALCIFIED RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING TWO PERCLOSE PROGLIDE DEVICES. PERCUTANEOUS CANNULATION OF THE VESSEL WAS REPORTEDLY PERFORMED PURPOSELY HIGH ABOVE THE MOST INFERIOR BORDER OF THE INFERIOR EPIGASTRIC ARTERY (IEA) AS THE PHYSICIAN INDICATED HE WANTED TO AVOID A RETROPERITONEAL BLEED. REPORTEDLY, AFTER FULLY ADVANCING THE KNOT TO THE VESSEL, BLEEDING CONTINUED. LEAVING THE SUTURE IN THE VESSEL, THE SUTURE FROM A SECOND PROGLIDE DEVICE WAS DEPLOYED; HOWEVER, AFTER FULLY ADVANCING THE KNOT TO THE VESSEL, BLEEDING CONTINUED. EMERGENT EXPLORATORY SURGERY FOUND THAT THERE WAS A BACK WALL PUNCTURE. PROTAMINE WAS INFUSED TO REVERSE THE ANTICOAGULANT EFFECTS OF HEPARIN. THE SUTURES WERE REMOVED AND THE VESSEL WAS SURGICALLY REPAIRED AND SUTURED TO ACHIEVE HEMOSTASIS. DUE TO THE REPORTED EXPERIENCE THERE WAS A SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354060 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30418K1

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention SHEATH: 6-FRENCH HEPARIN