BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2854502 · Received December 3, 2012

    Report

    Report Number
    2024168-2012-07632
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 22, 2012
    Report Date
    November 22, 2012
    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). INCORRECT SHEATH SIZE. THE PROSTAR XL 10 F SYSTEM IS DESIGNED FOR USE IN CONJUNCTION WITH 8.5 F TO 24 F SHEATHS. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED INABILITY TO OBTAIN MARKING WAS NOT CONFIRMED. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT BLOOD WAS PRESENT AT THE COILED SUTURE LUMENS INDICATING INSERTION INTO THE ANATOMY, BUT NO PRESENT AT THE MARKER LUMEN DUE TO COAGULATED BLOOD IN THE MARKER LUMEN. A NEEDLE WAS USED TO PUSH THE COAGULATED BLOOD LOOSE AND THE DEVICE WAS SUCCESSFULLY FLUSHED. BASED ON VISUAL AND FUNCTIONAL TESTING OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. REPORTEDLY, THE DEVICE WAS USED IN A 7FR ARTERIOTOMY SIZE. BASED ON THE REPORTED INFORMATION AND ANALYSIS OF THE RETURNED DEVICE, THE CAUSE FOR THE REPORTED EVENT WAS DETERMINED TO BE MOST LIKELY RELATED TO USER TECHNIQUE AND USE OF THE DEVICE OTHER THAN INTENDED, PER THE INSTRUCTIONS FOR USE (IFU). THE IFU STATES: THE PROSTAR XL 10 FR SYSTEM IS DESIGNED FOR USE IN CONJUNCTION WITH 8.5 FR TO 24 FR SHEATHS. 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 INDICATED 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

    IT WAS REPORTED THAT SUTURE PLACEMENT WAS ATTEMPTED WITH THE PROSTAR XL DEVICE IN THE RIGHT COMMON FEMORAL ARTERY (RCFA) PRIOR TO AN ENDOPROSTHESIS INTERVENTIONAL PROCEDURE. REPORTEDLY, DUE TO LOW BLOOD PRESSURE OF THE PATIENT IT WAS DIFFICULT TO GET AN ADEQUATE BLOOD FLOW FROM THE MARKER LUMEN. THE ARTERIOTOMY WAS 7 FR AND THE RCFA WAS NOT CALCIFIED AND NOT TORTUOUS. THE PROSTAR XL DEVICE WAS ATTEMPTED; HOWEVER, IT WAS NOT POSSIBLE TO OBTAIN MARKING. THE PHYSICIAN FLUSHED THE MARKER LUMEN BUT WITHOUT SUCCESS. THE PROSTAR XL HAD BEEN FLUSHED PRIOR TO USE IN THE PATIENT AND MARKER LUMEN FLOW WAS AS EXPECTED. A NEW PROSTAR XL DEVICE WAS USED, BLOOD FLOW OUT OF THE MARKER LUMEN WAS OBSERVED. HEMOSTASIS WAS ACHIEVED WITH THE SECOND DEVICE. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE IN-TRAINING IN THE USE OF THE PROSTAR XL DEVICE. 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 20406K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 7 FR, 11 FR. HEPARIN