BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE PILOT GUIDE WIRE

    MDR report key: 2760651 · Received September 26, 2012

    Report

    Report Number
    2024168-2012-06063
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 5, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K060449
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: (B)(4). THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED SEPARATION WAS CONFIRMED. BASED ON A VISUAL INSPECTION AND SCANNING ELECTRON MICROSCOPY IMAGING OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE PILOT GUIDEWIRE SEPARATED AT THE TORTUOUS AND CALCIFIED TARGET LESION IN THE MID RIGHT CORONARY ARTERY. THE GUIDEWIRE REACHED THE LESION BUT HAD NOT YET CROSSED IT. THE SEPARATED SEGMENT WAS SUCCESSFULLY REMOVED VIA A SNARE. THE PROCEDURE WAS THEN ABORTED. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH, A USER FACILITY MEDWATCH REPORT WAS RECEIVED AND STATES, "THE RCA (RIGHT CORONARY ARTERY) WAS ENGAGED USING A 7 FR AL 1 GUIDE CATHETER. ATTEMPT TO TRAVERSE THE CORONARY ARTERY WITH A 50 PILOT 300 CM GUIDEWIRE RESULTED IN A DISSECTION OF THE VESSEL (TYPE B) AND TRANSECTION OF THE DISTAL TIP OF THE WIRE. THE WIRE TIP WAS RETRIEVED WITH THE USE OF A SNARE DEVICE. PATIENT REMAINED STABLE WITH NO CHEST PAIN. THE DISSECTION WAS NON FLOW LIMITING, DID NOT PROPAGATE DISTALLY OR PROXIMALLY. PATIENT ADMITTED OVERNIGHT FOR OBSERVATION." THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE PILOT GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2042071

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention GUIDE CATHETER: 7 FR AL1