BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENRI

    MDR report key: 8733950 · Received June 26, 2019

    Report

    Report Number
    3002808904-2019-00015
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    May 28, 2019
    Report Date
    May 28, 2019
    Manufacturer
    KANEKA
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCERNED DEVICE "SENRI" IS A RAPID-EXCHANGE (RX) TYPE SEMI-COMPLIANT PTA BALLOON DILATATION CATHETER COMPATIBLE TO 0.018" GUIDEWIRE (GW). "SENRI" HAS NO APPROVAL IN THE US, HOWEVER, WE WILL REPORT THIS CASE AS AN INCIDENT OCCURRED ON A SIMILAR DEVICE FOR "CROSSTELLA RX" (A RX-TYPE PTA BALLOON DILATATION CATHETER, COMPATIBLE TO 0.018" GW) THAT IS DISTRIBUTED IN THE US UNDER 510(K) # K152873. THE DEVICE HISTORY RECORDS (DHR) OF THE DEVICE CONCERNED WAS REVIEWED: THE PRODUCTION LOT, TO WHICH THE DEVICE CONCERNED BELONGS, PASSED ALL IN-PROCESS INSPECTIONS FOR EVERY PRODUCT, AND THE FINISHED PRODUCT INSPECTIONS ON REPRESENTATIVE SAMPLES BASED ON SAMPLING PLAN. NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES OF THE DEVICE CONCERNED WAS FOUND. PROBABLE CAUSE(S) AND OUR COMMENT: WE SPECULATE THE REPORTED SITUATION AS FOLLOWS: DURING USE, A BALLOON WAS DAMAGED BY HAVING TOUCHED SOME KIND OF HARD THINGS AND BURST AT THE TIME OF EXPANSION. A PART OF THE BALLOON WHICH BURST AT THE TIME OF A WITHDRAWAL WAS CAUGHT ON THE TIP OF THE SHEATH OR AN ANASTOMOTIC REGION, AND THE CATHETER REACHED THE BREAK OF A BALLOON AND THE TIP BY LOAD OF THE EXCESSIVE PULLING. NO NONCONFORMITY OR ABNORMALITY WAS FOUND IN THE MANUFACTURING PROCESSES ACCORDING TO THE DHR. WE BELIEVE THE REPORTED PROBLEM WOULD NOT BE CAUSED BY ANY DEFECT OF THE DEVICE.

    Description of Event or Problem · 1

    PROCEDURE WAS AN AV FISTULOPLASTY. THIS "SENRI"PTA BALLOON CATHETER (HEREAFTER SAID "BALLOON CATHETER") WAS EMPLOYED FOR A DIALYSIS-SHUNT PTA. THE BALLOON OF THE PTA BALLOON CATHETER RUPTURED AT AN INFLATING. WHEN THE BALLOON CATHETER WAS REMOVED FROM THE SHEATH, DR. NOTED THAT THE DISTAL APPROXIMATELY 20MM OF THE BALLOON WAS MISSING AND THE BALLOON HAD BURST AROUND THE CIRCUMFERENCE INSTEAD OF LENGTHWISE ALONG THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529741 SENRI CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT KANEKA SP108512

    Patients

    Seq Age Sex Outcome Treatment
    1 Other