BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2083286 · Received May 10, 2011

    Report

    Report Number
    2024168-2011-03347
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THAT THE HANDLE WAS IN BACKDOWN POSITION. THE NEEDLES WERE STILL IN PRE-DEPLOYED POSITION AND THERE WERE NO SLACKS ON THE SUTURES. THE SHEATH APPEARED NORMAL. DURING THE INVESTIGATION, GUIDE WIRE PATENCY TESTING WAS PERFORMED. THE GUIDE WIRE WAS BACKLOADED AND FRONTLOADED WITHOUT A PROBLEM OR RESISTANCE. THE HEMOSTATIC VALVE AND EXIT RAMP WERE CHECKED AND BOTH WERE FOUND NORMAL. BASED ON THE INVESTIGATION, THE DEVICE PERFORMED ACCORDING TO SPECIFICATION; THEREFORE, THE CAUSE FOR THE REPORTED DIFFICULTY INSERTING THE PROSTAR XL SHEATH COULD NOT BE DETERMINED. HOWEVER, IT WAS REPORTED THAT THE PHYSICIAN INDICATED THAT SCAR TISSUE WAS THE REASON FOR THOSE DIFFICULTIES AND ALSO THE DIFFICULTIES WHEN INSERTING THE INTRODUCER SHEATH. IT WAS ALSO INDICATED THAT THE PUNCTURE PERFORMED AT THE ACCESS SITE WAS AN ANTEGRADE PUNCTURE. THE SAFETY AND EFFECTIVENESS OF THE PROSTAR XL DEVICE SYSTEM HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH ANTEGRADE PUNCTURES. A DEFINITIVE CAUSE COULD BE DETERMINED. WHETHER SCARRING OF THE FEMORAL ARTERY OR THE ANTEGRADE PUNCTURE CONTRIBUTED TO THE EVENT IS UNKNOWN. A REVIEW OF THE FINISHED PRODUCT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. IN ADDITION, A QUERY OF THE COMPLAINT DATABASE WAS PERFORMED AND THERE WERE NO OTHER COMPLAINTS WITHIN THIS LOT REPORTED FOR DIFFICULT TO INSERT SHEATH. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY. TO HELP ENSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INTIAL MEDWATCH REPORT ADDITIONAL INFORMATION INDICATES THE PUNCTURE AT THE CFA WAS PERFORMED ANTEGRADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE PROSTAR XL DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY AFTER A VALVE REPLACEMENT PROCEDURE. REPORTEDLY, THE PHYSICIAN CAREFULLY BACK-LOADED THE PROSTAR XL DEVICE OVER THE GUIDE WIRE (AS MENTIONED IN THE IFU), BUT AT ONE POINT, IT STOPPED. HE COULD NOT POSITION THE PROSTAR XL INTO THE PATIENT'S ANATOMY, THE DEVICE WAS STILL ABOVE THE SKIN LEVEL. THE DEVICE WAS REMOVED, THE GUIDE WIRE WAS KEPT IN PLACE AND A NEW PROSTAR XL DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THE PHYSICIAN INDICATED THAT SCAR TISSUE WAS THE REASON FOR THE DIFFICULTIES AND ALSO DIFFICULTY WAS EXPERIENCED WHILE INSERTING THE INTRODUCER SHEATH. THERE WERE NO ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 020216H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 0.014 GUIDE WIRE