BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE PULMONARY

    MDR report key: 21131342 · Received January 10, 2025

    Report

    Report Number
    3005099803-2024-06815
    Event Type
    Malfunction
    Date Received
    January 10, 2025
    Date of Event
    December 3, 2024
    Report Date
    March 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KTI
    UDI-DI
    08714729456209
    PMA / PMN Number
    K023337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G4: THE REMAINING PREMARKET/510(K) NUMBER IS K170759; REPORTED HERE AS PREMARKET/510(K) NUMBER EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A041001 CAPTURES THE REPORTABLE EVENT OF A BALLOON PINHOLE. BLOCK H11: INVESTIGATION RESULTS THE RETURNED CRE PULMONARY DILATATION BALLOON WAS ANALYZED, AND A VISUAL INSPECTION FOUND NO DAMAGE TO THE DEVICE. FUNCTIONAL AND MICROSCOPIC INSPECTION FOUND THAT THE BALLOON HAD A PINHOLE APPROXIMATELY 83 MM FROM THE DEVICE TIP. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED EVENT OF BALLOON PINHOLE WAS CONFIRMED. THE RESULTS OF THE ANALYSIS PERFORMED ON THE RETURNED DEVICE FOUND THAT THE BALLOON HAD A PINHOLE APPROXIMATELY 83 MM FROM THE DEVICE TIP. THE PINHOLE FOUND IS LIKELY TO HAVE OCCURRED DUE TO PROCEDURAL FACTORS SUCH AS EXCESS PRESSURE, INTERACTION WITH OTHER DEVICES, OR ANATOMICAL CONDITIONS. ALSO, IT IS POSSIBLE THAT INTERACTION WITH A SHARP SURFACE DURING OR PREVIOUS THE PROCEDURE COULD HAVE CAUSED THE PROBLEM FOUND ON THE DISTAL SECTION OF THE BALLOON. BASED ON ALL GATHERED INFORMATION, THE MOST PROBABLE ROOT CAUSE IS AN ADVERSE EVENT RELATED TO PROCEDURE.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A041001 CAPTURES THE REPORTABLE EVENT OF A BALLOON PINHOLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE TRACHEA DURING A BALLOON CATHETER DILATATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WATER LEAK WAS NOTICED DURING BALLOON DILATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: VIDEO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WERE PROVIDED BY THE CUSTOMER AND SHOWED THE WATER LEAKED THRU A PINHOLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE TRACHEA DURING A BALLOON CATHETER DILATATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WATER LEAK WAS NOTICED DURING BALLOON DILATION. IT WAS REPORTED THAT NO PRESSURE VALUE INDICATOR CARD WAS INCLUDED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: VIDEO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WERE PROVIDED BY THE CUSTOMER AND SHOWED THE WATER LEAKED THRU A PINHOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511633 CRE PULMONARY BRONCHOSCOPE ACCESSORY KTI BOSTON SCIENTIFIC CORPORATION M00550320 0031223271 08714729456209

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male