BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2023901 · Received March 18, 2011

    Report

    Report Number
    2024168-2011-01815
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. REPORTED DEVICE (B)(4): USE IN A CALCIFIED VESSEL, DEVICE ADVANCED AGAINST RESISTANCE. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. DEVICE #2 PROGLIDE, IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THAT THE PLUNGER WAS STILL IN THE PRE-DEPLOYED POSITION AND THERE WAS NO SLACK PRESENT ON THE LINK. THE SHEATH LOOKED NORMAL AND THERE WAS A KINK ON THE SHEATH JUST BELOW THE OVERMOLD AREA. LOT TESTING FOR HYDROPHILIC COATING WAS CONFIRMED TO BE WITHIN SPECIFICATIONS. AFTER A DEVICE IS INSERTED INTO THE PATIENT IT IS NOT POSSIBLE TO CHECK THE HYDROPHILIC COATING, BECAUSE IT IS DIFFICULT TO QUANTIFY ITS PRESENCE ONCE THE DEVICE HAS BEEN DEPLOYED. DURING TESTING, THE GUIDEWIRE WAS BACKLOADED AND FRONTLOADED WITHOUT A PROBLEM. THE MARKING PATENCY WAS CHECKED AND THE DEVICE WAS PATENT; HOWEVER, IT WAS REPORTED THAT THE PROGLIDE DEVICE WAS USED FOR ARTERIOTOMY CLOSURE OF A MODERATELY SCARRED AND MILDLY CALCIFIED FEMORAL ARTERY. WHETHER CALCIFICATION OF THE FEMORAL ARTERY CONTRIBUTED TO THE EVENT IS UNKNOWN. THE PROBABLE ROOT CAUSE FOR THE SHEATH KINK IS DUE TO ANATOMICAL CONDITIONS SUCH AS HEAVILY SCARRED TISSUE, A TIGHT TISSUE TRACT OR IF THE OPERATOR AGGRESSIVELY ADVANCES THE DEVICE. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR DIFFICULTY INSERTING THE SHEATH OR KINK DAMAGE WITH THIS LOT.

    Description of Event or Problem · 1

    THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: ALTHOUGH IT WAS INITIALLY REPORTED THAT A HEMATOMA LESS THAN 5MM DEVELOPED AT THE GROIN SITE, NEW INFORMATION INDICATES THE HEMATOMA WAS LARGER THAN INITIALLY REPORTED; THE SIZE WAS NOT SPECIFIED. HOSPITALIZATION WAS EXTENDED A FEW DAYS AND THE PATIENT WAS DISCHARGED TO HOME. A FEW DAYS LATER THE PATIENT RETURNED. CT SCAN REVEALED A PSEUDOANEURYSM THAT WAS TREATED WITH THROMBIN INJECTION. THE PATIENT WAS SENT HOME. THE PATIENT RETURNED AGAIN COMPLAINING OF GROIN AND LEG PAIN. CT SCAN WAS DONE. NO PULSES WERE FOUND IN THE LEG. A CLOT WAS SURGICALLY REMOVED FROM BEHIND THE KNEE. POST-OPERATIVELY, DIMINISHED PULSES WERE FOUND IN THE FOOT, HOWEVER, NO TREATMENT WAS GIVEN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A MODERATELY SCARRED AND MILDLY CALCIFIED COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC CORONARY ANGIOGRAPHIC PROCEDURE. REPORTEDLY, DURING DEVICE INSERTION, DIFFICULTY WAS ENCOUNTERED AND ARTERIAL LUMINAL MARKING COULD NOT BE ACHIEVED. THE DEVICE WAS REMOVED OVER A GUIDE WIRE REVEALING A KINK DISTAL TO THE FOOT. IT WAS BELIEVED THAT THE DEVICE KINKED DUE TO SCAR TISSUE AT THE GROIN SITE AND ADDITIONAL PRESSURE THAT WAS APPLIED TO ADVANCE THE DEVICE. A SECOND PROGLIDE DEVICE WAS ATTEMPTED, BUT ALTHOUGH ONLY MINIMAL BLOOD WAS OBSERVED FROM THE MARKER LUMEN, DEVICE DEPLOYMENT WAS ATTEMPTED; HOWEVER, THE SUTURES DID NOT CAPTURE ARTERIAL TISSUE. A HEMATOMA LESS THAN 5MM AND TENDERNESS DEVELOPED AT THE GROIN SITE. MANUAL COMPRESSION WAS USED TO EXPRESS THE HEMATOMA AND ACHIEVE HEMOSTASIS. A COMPUTED TOMOGRAPHY SCAN WAS NEGATIVE FOR A RETROPERITONEAL HEMORRHAGE. THE PATIENT WAS MONITORED OVERNIGHT, THE TENDERNESS RESOLVED, AND THE PATIENT WAS DISCHARGED TO HOME THE NEXT DAY. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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 970046H

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R