BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATH INF .038 F4 100 JR-4

    MDR report key: 2001470 · Received February 25, 2011

    Report

    Report Number
    9616099-2011-00137
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K862244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING USE THE INFINITY JR 4 CATHETER TIP FRACTURED / SEPARATED IN THE PATIENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION; HOWEVER, TO DATE, NO MORE DETAILS HAVE BEEN AVAILABLE. THERE ARE NO PATIENT, VESSEL OR LESION CHARACTERISTICS AVAILABLE. THE REPORT RECEIVED FROM THE FIELD INDICATED THAT DURING A DIAGNOSTIC CARDIAC CATHETERIZATION, THE DISTAL TIP OF THE 4 FR INFINITY JR4 100 CM. DIAGNOSTIC CATHETER SEPARATED/DISLODGED IN THE PATIENT. THERE IS NO INFORMATION REGARDING TREATMENT OF THE SEPARATED TIP OR RETRIEVAL EFFORTS. THERE WAS NO REPORT OF INJURY FOR THE PATIENT. THE PRODUCT WAS RETURNED FOR INSPECTION. ONE NON STERILE 4F DIAGNOSTIC CATHETER WAS RECEIVED COILED IN A PLASTIC BAG. THE CATHETER BRITE TIP IS MISSING. WHITE TIP TRACES WERE FOUND AROUND FUSING SURFACE. NO OTHER ANOMALIES WERE FOUND. THE CATHETER OUTER AND INNER DIAMETER WAS MEASURED NEXT TO TIP SEPARATION AREA AND WAS FOUND WITHIN SPECIFICATION. ACCORDING TO THE SEM ANALYSIS, ELONGATIONS AND TIP REMAINS CAN BE OBSERVED THROUGH SOME PORTIONS OF THE CIRCUMFERENCE OF THE TIP; ELONGATIONS ARE A CHARACTERISTIC THAT SUGGEST POSSIBLE STRETCHING. NO VISUAL EVIDENCE OF ANY CHEMICAL DEGRADATION WAS NOTED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE TIP SEPARATION WAS CONFIRMED. THE EXACT CAUSE OF SEPARATION COULD NOT BE CONCLUSIVELY DETERMINED, BUT IT DOES NOT APPEAR TO BE MANUFACTURING RELATED SINCE ELONGATION AND FUSING EVIDENCE WAS NOTED PER SEM ANALYSIS REPORT. HOWEVER, PROCEDURAL FACTORS MAY HAVE CONTRIBUTED WITH REPORTED EVENT. THEREFORE, NO CORRECTIVE/PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE TIP FRACTURE / SEPARATED COMPLAINT WAS CONFIRMED ON ANALYSIS. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE VERY LIMITED INFORMATION DOES NOT ALLOW FOR A CLINICAL CONCLUSION TO BE MADE REGARDING POSSIBLE CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT DURING A DIAGNOSTIC CARDIAC CATHETERIZATION, THE DISTAL TIP OF THE 4 FR. INFINITY JR4 100 CM. DIAGNOSTIC CATHETER SEPARATED/DISLODGED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH INF .038 F4 100 JR-4 DIAGNOSTIC CARDIOLOGY CATHETER (DQO) DQO CORDIS DE MEXICO NA 15294594

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R