BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENRI

    MDR report key: 21822870 · Received April 11, 2025

    Report

    Report Number
    3002808904-2025-00013
    Event Type
    Injury
    Date Received
    April 11, 2025
    Date of Event
    March 14, 2025
    Report Date
    March 14, 2025
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONCERNED DEVICE SUBJECT TO THIS REPORTED EVENT, "SENRI", AN RX-TYPE PTA BALLOON CATHETER COMPATIBLE WITH 0.018" GUIDEWIRE(GW), IS NOT DISTRIBUTED IN THE US, HOWEVER, WE INTEND TO REPORT THIS CASE AS THE EVENT OCCURRED ON ONE OF THE SIMILAR DEVICES FOR"CROSSTELLA RX PTA BALLOON DILATATION CATHETER" DISTRIBUTED IN THE US UNDER 510(K) # K152873. 1. RESULTS OF INVESTIGATION: 1) THREE RUPTURES WERE IDENTIFIED ON THE BALLOON APPROXIMATELY 53 TO 58 MM FROM THE DISTAL TIP. ADDITIONALLY, A SHAFT FRACTURE WAS OBSERVED AT APPROXIMATELY 380 MM FROM THE DISTAL TIP. 2) THE DEVICE HISTORY RECORDS (DHR) OF THE DEVICE CONCERNED WERE 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. 2. PROBABLE CAUSE AND COMMENTS: ALL RESIDUAL FRAGMENTS WERE SUCCESSFULLY RETRIEVED; HOWEVER, SURGICAL INTERVENTION WAS REQUIRED FOR THEIR REMOVAL. THEREFORE, THE EVENT WAS ASSESSED AS A SERIOUS INJURY. BASED ON THE INVESTIGATION, THE EVENT IS CONSIDERED TO BE PROCEDURE-RELATED, LIKELY CAUSED BY EXCESSIVE TRACTION APPLIED AFTER BALLOON DEFLATION WHILE THE DEVICE REMAINED ENTANGLED WITH THE STENT. NO ISSUES WERE IDENTIFIED WITH THE PRODUCT'S DESIGN OR MANUFACTURING.

    Description of Event or Problem · 0

    THE DEVICE WAS USED TO PERFORM ANGIOPLASTY ON A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. AFTER BALLOON INFLATION AND SUBSEQUENT DEFLATION, AN ATTEMPT WAS MADE TO WITHDRAW THE DEVICE. DURING WITHDRAWAL, THE BALLOON BECAME CAUGHT ON A PREVIOUSLY IMPLANTED ILIAC STENT, RESULTING IN BALLOON RUPTURE. SURGICAL INTERVENTION WAS PERFORMED, AND THE RETAINED BALLOON FRAGMENT WAS SUCCESSFULLY RETRIEVED. AN ARTERIOTOMY WAS CONDUCTED TO REMOVE THE RETAINED BALLOON MATERIAL, FOLLOWED BY VASCULAR REPAIR THROUGH SUTURING. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104027 SENRI PTA BALLOON DILATATION CATHETER LIT KANEKA CORPORATION SR122326

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other