BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPN NC 3.0X15 PTCA DILATATION CATHETER

    MDR report key: 23930997 · Received December 30, 2025

    Report

    Report Number
    3013634084-2025-00005
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    November 11, 2025
    Report Date
    February 27, 2025
    Manufacturer
    SIS MEDICAL AG
    Product Code
    LOX
    UDI-DI
    07640142570608
    PMA / PMN Number
    K212393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DHR HAS BEEN PERFORMED AND THE LOT IS WITHIN SPECIFICATIONS. FURTHER INVESTIGATION WILL BE CONDUCTED ONCE THE DEVICE IS RETURNED.

    Additional Manufacturer Narrative · 0

    A COMPREHENSIVE REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE SUBJECT LOT WAS MANUFACTURED, PROCESSED, AND TESTED IN ACCORDANCE WITH APPROVED SPECIFICATIONS. THE PRODUCT INVOLVED IN THE COMPLAINT WAS RETURNED FOR INVESTIGATION ON 23.JAN.2026. A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE AND DURING THE INVESTIGATION THE ALLEGED BALLOON BURST WAS CONFIRMED. SEVERAL KINKS WERE OBSERVED IN THE HYPOTUBE. THE COMPLAINT FORM WAS RECEIVED AND THE INFORMATION REPORTED, INCLUDING ANY ADDITIONAL INFORMATION PROVIDED, WAS TAKEN INTO CONSIDERATION FOR THE TECHNICAL INVESTIGATION. IT WAS REPORTED THAT THE BALLOON RUPTURED WHILE BEING INFLATED AT APPROX. 22 ATM AFTER APPROX. 15 SECONDS DURING THE PROCEDURE. A 100% VISUAL INSPECTION OF THE FINAL PRODUCT WAS PERFORMED AND PRODUCT REF. 300-015-004 LOT 218313 FULFILLED ALL SPECIFICATIONS AT THE TIME OF BATCH RELEASE. AT THIS TIME, IT REMAINS UNCLEAR WHETHER THE PATIENT HAD SIGNIFICANT STENOSIS, CALCIFIED PLAQUE, OR OTHER LESION CHARACTERISTICS THAT MAY HAVE INCREASED RESISTANCE TO BALLOON EXPANSION AND CONTRIBUTED TO THE REPORTED RUPTURE AT 22 ATM. ADDITIONALLY, BALLOON DAMAGE CANNOT BE EXCLUDED DURING DEVICE PREPARATION OR HANDLING PRIOR TO INSERTION. COMPLAINTS FOR THE LAST 3 YEARS WERE REVIEWED, AND THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE AVAILABLE INFORMATION AND VISUAL INSPECTION, THE EXACT ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED BALLOON RUPTURE IS POSSIBLY RELATED TO CIRCUMSTANCES OF THE PROCEDURE. AS THERE WAS NO LEAK NOTED DURING PREPARATION, THIS DOES NOT SUGGEST A PRODUCT QUALITY ISSUE.

    Description of Event or Problem · 0

    THE COMPLAINANT STATED THAT HE OPN BALLOON BROKE WHEN IT REACHED 22 ATMOSPHERES FOR APPROXIMATELY 15 SECONDS EVEN THOUGH IT IS MANUFACTURED TO WITHSTAND 34 ATMOSPHERES. THE COMPLAINANT REPORTS THAT THE PATIENT DIDN'T' HAVE A STENT, THAT THE EVENT DID NOT AFFECT THE PATIENT, AND THAT THE STENT WAS EVENTUALLY SUCCESSFULLY PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369078 OPN NC 3.0X15 PTCA DILATATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS (PTCA CATHETER) LOX SIS MEDICAL AG OPN NC 218313 07640142570608

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown