BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGREAT CATHETER

    MDR report key: 4589501 · Received March 11, 2015

    Report

    Report Number
    9681834-2015-00028
    Event Type
    Injury
    Date Received
    March 11, 2015
    Date of Event
    February 19, 2015
    Report Date
    March 11, 2015
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    KRA
    PMA / PMN Number
    K033913
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS STATED, THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP #1 FOR MFG. REPORT # 9681834-2015-00028 TO PROVIDE ADDITIONAL INFORMATION FOR THE RETURNED PHOTO EVALUATION AND THE RETENTION SAMPLE EVALUATION. RESULTS/CONCLUSION - BASED ON EVALUATION OF USER FACILITY INFORMATION & THE RETURNED PHOTO; BASED UPON EVALUATION OF THE RETENTION SAMPLES. THE INVOLVED DEVICE WAS NOT RETURNED TO THE MANUFACTURING FACILITY BUT A PHOTO WAS PROVIDED BY THE USER FACILITY. THEREFORE, THE INVESTIGATION WAS LIMITED TO ASSESSMENT OF INFORMATION PROVIDED BY THE USER FACILITY, EVALUATION OF RETENTION SAMPLES FROM THE SAME PRODUCT CODE AND THE PRESUMED LOT NUMBERS 140826 AND 140930. THE PHOTO OF THE ACTUAL SAMPLE REVELED A FRACTURED AT THE DISTAL SEGMENT, WITH THE FRACTURED PIECE MISSING. THE SHAFT HAD BEEN STRETCHED, EXPOSING THE INNER LAYER AT THE DISTAL END. VISUAL INSPECTION OF THE RETENTION SAMPLES DID NOT REVEAL ANY ANOMALIES ON THE SHAFT ALONG THE TOTAL LENGTH. MAGNIFYING INSPECTION OF THE SURFACE DID NOT REVEAL ANY ANOMALIES. THE OUTSIDE AND INSIDE DIAMETERS WERE CONFIRMED TO MEET MANUFACTURER SPECIFICATIONS. THE TENSILE STRENGTH WAS DETERMINED AT APPROXIMATELY 5 MM FROM THE DISTAL END WITH THE LOAD MEASURING MACHINE. THE RETENTION SAMPLE WAS FOUND TO MEET MANUFACTURER SPECIFICATIONS, BEING COMPARABLE TO THAT OF THE CURRENT PRODUCT SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FOR THE INVOLVED PRODUCT CODE/LOT# COMBINATIONS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS PRODUCT CODE/LOT# COMBINATION HAS NOT BEEN REPORTED PREVIOUSLY. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. ALTHOUGH THE EXACT CAUSE CANNOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION, IT IS LIKELY THAT THE ACTUAL SAMPLE WAS SUBJECTED TO AN EXTERNAL FORCE, INCLUDING A TENSILE FORCE, AND BECAME FRACTURED. ALL CURRENTLY AVAILABLE INFORMATION HAS BEEN PLACED ON FILE BY QA AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    THE LOT # FOR THIS PRODUCT CODE IS UNKNOWN. IT WAS PRESUMED TO BE EITHER 140826 OR 140930 PER THE REPORTER. THE INVOLVED DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE INVESTIGATION WAS BASED UPON THE EVALUATION OF USER FACILITY INFORMATION, AND RETENTION SAMPLES FROM THE PRESUMED INVOLVED PRODUCT CODE (LOT # 140826 AND 140930). VISUAL INSPECTION OF THE RETENTION SAMPLE DID NOT REVEAL ANY ANOMALIES. MAGNIFYING INSPECTION OF THE SURFACE DID NOT REVEAL ANY ANOMALIES. THE OUTSIDE AND INSIDE DIAMETERS WERE MEASURED AND CONFIRMED TO MEET MANUFACTURER SPECIFICATIONS. A REVIEW OF THE MANUFACTURING HISTORY RECORD OF THE INVOLVED PRODUCT/LOT# COMBINATION CONFIRMED THAT THERE WERE NO INDICATIONS OF PRODUCTION RELATED PROBLEMS. A SEARCH OF THE COMPLAINT FILE DID NOT FIND ANY OTHER REPORT WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE INVESTIGATION RESULTS VERIFIED THAT THE RETENTION SAMPLES ARE THE NORMAL PRODUCT WITH NO INHERENT DEFICIENCY WHICH WOULD NOT RELATE TO THE REPORTED COMPLAINT. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP #1 FOR MFG. REPORT # 9681834-2015-00028 TO PROVIDE ADDITIONAL INFORMATION FOR THE RETURNED PHOTO EVALUATION AND THE RETENTION SAMPLE EVALUATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WHILE INFLATING A BALLOON ACROSS THE PULMONARY ARTERY IT BECAME APPARENT TO THE PHYSICIAN THAT A PORTION OF THE TIP OF THE PROGREAT THEY WERE PREVIOUSLY USING HAD BROKEN OFF FROM THE CATHETER AND WAS IN THE PULMONARY ARTERY. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: (1) WAS UNABLE TO REMOVE THE ENTIRE DISLODGED PORTION; (2) HAD TO LEAVE BEHIND WHAT THEY BELIEVE TO BE THE RADIOPAQUE MARKER; AND (3) THE PROCEDURE WAS COMPLETED IN THE NORMAL MANNER OUTSIDE OF REMOVING THE MARKER BAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167335 PROGREAT CATHETER CATHETER KRA TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 02 YR Other WHISPER WIRE| CORDIS SHEATH| BALLOON| GLIDESHEATH