BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAVVY LONG OTW PTA CATHETER

    MDR report key: 8648383 · Received May 28, 2019

    Report

    Report Number
    9616666-2019-00064
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    November 6, 2015
    Report Date
    July 5, 2022
    Manufacturer
    CLEARSTREAM TECHNOLOGIES LTD.
    Product Code
    LIT
    PMA / PMN Number
    K072947
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A MANUFACTURING REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE RESULT OF THE INVESTIGATION IS INCONCLUSIVE FOR THE VESSEL PERFORATION ISSUE REPORTED. WHILE THE JOURNAL ARTICLE IDENTIFIED THAT THE VESSEL WAS PERFORATED THE DEFINITIVE ROOT CAUSE FOR THE VESSEL PERFORATION ISSUE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. LABELING REVIEW: THE INSTRUCTION FOR USE FOR THE SAVVY LONG PRODUCT WAS REVIEWED AND CONTAINS THE FOLLOWING INFORMATION RELEVANT TO THE REPORTED EVENT: ADVERSE EFFECTS: POSSIBLE ADVERSE EFFECTS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: VESSEL PERFORATION. EUI-YONG JEON, YOUNG KWON CHO, DAE YOUNG YOON, DAE JUNG KIM AND JEONG JOO WOO (2015). CLINICAL OUTCOME OF ANGIOSOME-ORIENTED INFRAPOPLITEAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY FOR ISOLATED INFRAPOPLITEAL LESIONS IN PATIENTS WITH CRITICAL LIMB ISCHEMIA. DIAGN INTERV RADIOL, 22: 52¿58. DOI 10.5152/DIR.2015.15129. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE IN THE DIAGN INTERV RADIOL (DIR) INTERVENTIONAL RADIOLOGY TITLED, "CLINICAL OUTCOME OF ANGIOSOME-ORIENTED INFRAPOPLITIEAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY FOR ISOLATED INFRAPOPLITEAL LESIONS IN THE PATIENTS WITH CRITICAL LIMB ISCHEMIA" THAT TWO PATIENTS HAD AN ARTERIAL PERFORATION WITH SEVERE BLEEDING AFTER INFRAPOPLITEAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (IP-PTA) FOR LESION OF THE ARTERIOR TIBIAL ARTERY (ATA), TREATED WITH PROLONGED BALLOON TAMPONADE, AND COIL EMBOLIZATION AND ADDITIONAL RECANALIZATION ON THE NON-TARGET ARTERY.

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A MANUFACTURING REVIEW 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) IS 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN THE DIAGN INTERV RADIOL (DIR) INTERVENTIONAL RADIOLOGY TITLED, "CLINICAL OUTCOME OF ANGIOSOME-ORIENTED INFRAPOPLITIEAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY FOR ISOLATED INFRAPOPLITEAL LESIONS IN THE PATIENTS WITH CRITICAL LIMB ISCHEMIA" THAT TWO PATIENTS HAD AN ARTERIAL PERFORATION WITH SEVERE BLEEDING AFTER INFRAPOPLITEAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (IP-PTA) FOR LESION OF THE ARTERIOR TIBIAL ARTERY (ATA), TREATED WITH PROLONGED BALLOON TAMPONADE, AND COIL EMBOLIZATION AND ADDITIONAL RECANALIZATION ON THE NON-TARGET ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440766 SAVVY LONG OTW PTA CATHETER PTA DILATATION CATHETER LIT CLEARSTREAM TECHNOLOGIES LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention