BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

    MDR report key: 7206508 · Received January 19, 2018

    Report

    Report Number
    3006513822-2018-00004
    Event Type
    Injury
    Date Received
    January 19, 2018
    Date of Event
    December 6, 2017
    Report Date
    April 30, 2018
    Manufacturer
    C.R. BARD, INC. (GFO)
    Product Code
    ONU
    UDI-DI
    00801741123054
    PMA / PMN Number
    P130024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: PRODUCT CLASSIFICATION CODE HAS BEEN CHANGED FROM "PRC" TO "ONU." THE PMA/510(K)# HAS BEEN CHANGED FROM "P170003" TO "P130024." THE SAMPLES WERE NOT RETURNED FROM THE USER FACILITY; THEREFORE, THE DEVICE EVALUATIONS ARE UNABLE TO BE PERFORMED. A LOT HISTORY REVIEW REVEALED ONE ADDITIONAL REOCCLUSION COMPLAINT WAS ASSOCIATED WITH THE SAME PATIENT FOR THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATES THE LOT WAS MANUFACTURED TO SPECIFICATION. CONCLUSION: THE ACTUAL SAMPLES WERE NOT RECEIVED FOR EVALUATION. THE DHR FOUND NOTHING TO INDICATE A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THE INVESTIGATOR ASSESSED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE, BUT POSSIBLY RELATED TO THE PROCEDURE AND DEFINITELY RELATED TO THE AV ACCESS CIRCUIT. BASED ON THE INSTRUCTIONS FOR USE (IFU), THE OCCURRENCE OF REOCCLUSION IS AN INHERENT RISK OF ANY PTA PROCEDURE, AND HAS BEEN REPORTED IN CLINICAL TRIALS OF DRUG COATED BALLOONS. IF ADDITIONAL INFORMATION BECOMES KNOWN TO THE MANUFACTURER, A SUPPLEMENTAL REPORT WILL BE PROVIDED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT CEPHALIC VEIN OF THE UPPER ARM. APPROXIMATELY 2 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT CEPHALIC VEIN CONTAINING THE TARGET LESION WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICES, BUT POSSIBLY RELATED TO PROCEDURE, AND DEFINITELY RELATED TO AV ACCESS CIRCUIT. THE SAMPLES WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBER IS 3006513822-2018-00003.

    Additional Manufacturer Narrative · 1

    ANALYSIS: THE SAMPLES WERE NOT RETURNED FROM THE USER FACILITY; THEREFORE, THE DEVICE EVALUATIONS ARE UNABLE TO BE PERFORMED. A LOT HISTORY REVIEW REVEALED ONE ADDITIONAL REOCCLUSION COMPLAINT WAS ASSOCIATED WITH THE SAME PATIENT FOR THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATES THE LOT WAS MANUFACTURED TO SPECIFICATION. CONCLUSION: THE ACTUAL SAMPLES WERE NOT RECEIVED FOR EVALUATION. THE DHR FOUND NOTHING TO INDICATE A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THE INVESTIGATOR ASSESSED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE, BUT POSSIBLY RELATED TO THE PROCEDURE AND DEFINITELY RELATED TO THE AV ACCESS CIRCUIT. BASED ON THE INSTRUCTIONS FOR USE (IFU), THE OCCURRENCE OF REOCCLUSION IS AN INHERENT RISK OF ANY PTA PROCEDURE, AND HAS BEEN REPORTED IN CLINICAL TRIALS OF DRUG COATED BALLOONS. IF ADDITIONAL INFORMATION BECOMES KNOWN TO THE MANUFACTURER, A SUPPLEMENTAL REPORT WILL BE PROVIDED WITH ALL RELEVANT INFORMATION. THE INFORMATION PROVIDED BY BARD 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 BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT CEPHALIC VEIN OF THE UPPER ARM. APPROXIMATELY 2 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT CEPHALIC VEIN CONTAINING THE TARGET LESION WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICES, BUT POSSIBLY RELATED TO PROCEDURE, AND DEFINITELY RELATED TO AV ACCESS CIRCUIT. THE SAMPLES WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBER IS 3006513822-2018-00003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48700 LUTONIX 035 DRUG COATED BALLOON PTA CATHETER DRUG COATED BALLOON PTA CATHETER ONU C.R. BARD, INC. (GFO) 9004 GFBP0757 00801741123054

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention