BEUDAMED
    FDA Adverse Event Death Summary report: N

    SLEEK RX PTA CATHETER

    MDR report key: 16547150 · Received March 15, 2023

    Report

    Report Number
    9616666-2023-00032
    Event Type
    Death
    Date Received
    March 15, 2023
    Date of Event
    July 19, 2021
    Report Date
    March 23, 2023
    Manufacturer
    CLEARSTREAM TECHNOLOGIES LTD.
    Product Code
    LIT
    PMA / PMN Number
    K072947
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: DATE OF DEATH FOR THE PATIENTS WERE NOT PROVIDED, DATE OF DEATH UPDATED AS (B)(6) 1900 FOR THE MDR SUBMISSION REQUIREMENT. H10: AS THIS DEATH IS CONSIDERED ONE EVENT IDENTIFIED BY THE DEALER; ONLY ONE MDR REPORT WILL BE SUBMITTED FOR THE REPORTED QUANTITY AFFECTED OF SIX FOR THIS EVENT. H10: MANUFACTURING REVIEW: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO DEVICE MALFUNCTION WAS REPORTED. HOWEVER, THE RESULT OF THE INVESTIGATION IS CONFIRMED FOR THE REPORTED ADVERSE EVENT PATIENTS EXPIRED POSTOPERATIVE FOLLOW UP. THE CAUSE OF DEATH IS UNKNOWN. THE DEFINITIVE ROOT CAUSE FOR THE REPORTED ADVERSE EVENT PATIENTS EXPIRED POSTOPERATIVE FOLLOW UP COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION RECEIVED FROM THE FIELD COMMUNICATIONS. LABELING REVIEW: INSTRUCTIONS FOR USE FOR SLEEK PTA RAPID EXCHANGE (RX) DILATATION CATHETER PRODUCT FAMILY WAS REVIEWED THE FOLLOWING SECTIONS ARE APPLICABLE: INDICATIONS: THE SLEEK CATHETERS ARE INTENDED FOR BALLOON DILATATION OF THE FEMORAL, POPLITEAL AND INFRA-POPLITEAL ARTERIES. THESE CATHETERS ARE NOT DESIGNED TO BE USED IN THE CORONARY ARTERIES. ADVERSE EFFECTS: POSSIBLE ADVERSE EFFECTS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: ¿ DEATH. STORAGE: STORE IN A COOL, DARK, DRY PLACE. USE THE CATHETER PRIOR TO THE ¿USE BY¿ DATE SPECIFIED ON THE PACKAGE. H10: G3. H11: H6 (METHOD). H10: ARTUR KOTOV, FREDERIK PETERS, EIKE SEBASTIAN DEBUS, THOMAS ZELLER, PETER HEIDER, CHRISTIAN-ALEXANDER BEHRENDT, ET AL. (2021). THE PROSPECTIVE GERMANVASC COHORT STUDY. VASA . JOURNAL OF VASCULAR DISEASES, 50(6):446-452. DOI: 10.1024/0301-1526/A000966. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Additional Manufacturer Narrative · 0

    DATE OF DEATH FOR THE PATIENTS WERE NOT PROVIDED, DATE OF DEATH UPDATED AS 01-JAN-1900 FOR THE MDR SUBMISSION REQUIREMENT. AS THIS DEATH IS CONSIDERED ONE EVENT IDENTIFIED BY THE DEALER; ONLY ONE MDR REPORT WILL BE SUBMITTED FOR THE REPORTED QUANTITY AFFECTED OF SIX FOR THIS EVENT. AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) ARE ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. ARTUR KOTOV, FREDERIK PETERS, EIKE SEBASTIAN DEBUS, THOMAS ZELLER, PETER HEIDER, CHRISTIAN-ALEXANDER BEHRENDT, ET AL. (2021). THE PROSPECTIVE GERMANVASC COHORT STUDY. VASA . JOURNAL OF VASCULAR DISEASES, 50(6):446-452. DOI: 10.1024/0301-1526/A000966

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE IN JOURNAL OF ¿VASA¿ TITLED ¿THE PROSPECTIVE GERMANVASC COHORT STUDY", THAT APPROXIMATELY SOMETIME POST PROCEDURE, OF TWENTY-EIGHT PATIENTS WHO HAD POSTOPERATIVE FOLLOW-UP WITHIN TWELVE-MONTHS, SIX PATIENTS WERE REPORTEDLY EXPIRED AND THE PRIMARY CAUSE OF DEATH WAS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE IN JOURNAL OF ¿VASA¿ TITLED ¿THE PROSPECTIVE GERMANVASC COHORT STUDY", THAT APPROXIMATELY SOMETIME POST PROCEDURE, OF TWENTY-EIGHT PATIENTS WHO HAD POSTOPERATION FOLLOW-UP WITHIN TWELVE-MONTHS, SIX PATIENTS WERE REPORTEDLY EXPIRED AND THE PRIMARY CAUSE OF DEATH WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757487 SLEEK RX PTA CATHETER PTA BALLOON DILATATION CATHETER LIT CLEARSTREAM TECHNOLOGIES LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death