BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT GRAPHIX (TM)

    MDR report key: 2233352 · Received September 2, 2011

    Report

    Report Number
    2134265-2011-03631
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    May 30, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K950835
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT ANALYSIS REVEALED THE DISTAL TIP IS NOT FRACTURED; HOWEVER, THE TIP IS OBSERVED TO BE FLAT AND APPROXIMATELY 1CM OF POLY COATING IS MISSING. THE LENGTH OF THE WIRE IS 299.7CM. ALL OUTER DIAMETER MEASUREMENTS MET SPECIFICATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A GUIDE WIRE DETACHMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE 'STRONG CALCIFIED" PERONEAL ARTERY. THE 300CM PT GRAPHIX GUIDE WIRE WAS ADVANCED INTO THE PATIENT. AS THE PHYSICIAN STARTED TO WITHDRAW THE WIRE IN ORDER TO INSERT INTO AN UNSPECIFIED BALLOON, THE TIP OF THE WIRE WAS TORN, BUT HAD A "THIN WIRE LEFT CONNECTED". HE PULLED ON THE WIRE AGAIN AND THE TIP DETACHED AND MOVED TO A "BLIND SEGMENT THAT DOES NOT HARM THE PATIENT HEALTH" IN THE OCCLUDED PERONEAL ARTERY. NO ATTEMPTS WERE MADE TO REMOVE THE WIRE FRAGMENT WHICH MEASURES 2-3MM. THE LESION IN THE PERONEAL ARTERY WAS NOT TREATED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A GUIDE WIRE DETACHMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE "STRONG CALCIFIED" PERONEAL ARTERY. THE 300CM PT GRAPHIX GUIDE WIRE WAS ADVANCED INTO THE PATIENT. AS THE PHYSICIAN STARTED TO WITHDRAW THE WIRE IN ORDER TO INSERT INTO AN UNSPECIFIED BALLOON, THE TIP OF THE WIRE WAS TORN, BUT HAD A "THIN WIRE LEFT CONNECTED". HE PULLED ON THE WIRE AGAIN AND THE TIP DETACHED AND MOVED TO A "BLIND SEGMENT THAT DOES NOT HARM THE PATIENT HEALTH" IN THE OCCLUDED PERONEAL ARTERY. NO ATTEMPTS WERE MADE TO REMOVE THE WIRE FRAGMENT WHICH MEASURES 2-3MM. THE LESION IN THE PERONEAL ARTERY WAS NOT TREATED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT GRAPHIX (TM) WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA H74914914011

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention