BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRIDGE OCCLUSION BALLOON

    MDR report key: 25191835 · Received May 15, 2026

    Report

    Report Number
    3007284006-2026-00227
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    April 5, 2021
    Report Date
    August 25, 2025
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MJN
    PMA / PMN Number
    K203540
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE - STANDARD GROUP MEAN AGE OF 64.3± 14.8 YEARS. ABBREVIATED GROUP: MEAN AGE OF 59.7± 14.6 YEARS. A3) PATIENT SEX: STANDARD GROUP: 26 MALES AND 16 FEMALES. ABBREVIATED GROUP: 26 MALES AND 16 FEMALES. A3B-A6) SPECIFIC PATIENT/CASE DETAIL WAS NOT PROVIDED. B4) DATE LISTED IS THE DATE THE MANUFACTURER BECAME AWARE. B6) PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY DATA - SPECIFIC PATIENT/CASE DETAIL WAS NOT PROVIDED. D4/H4) THE LOT NUMBER WAS NOT PROVIDED; THUS THE FOLLOWING INFORMATION IS UNKNOWN: DEVICE SERIAL NUMBER, UNIQUE ID, EXPIRATION DATE, AND MANUFACTURE DATE. E) ALTHOUGH THE JOURNAL ARTICLE ORIGINATED FROM THE UNITED STATES, PHYSICIAN AND FACILITY INFORMATION ARE UNKNOWN; THEREFORE, THE INFORMATION LISTED IS THE CORRESPONDING AUTHOR OF THE JOURNAL ARTICLE. G3) THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW FOR LITERATURE MDR PER CAPA 207. H3) THE DEVICE WAS DISCARDED, THUS NO PRODUCT INVESTIGATION WAS PERFORMED. H6) PER IFU, THROMBOSIS IS LISTED AS A POTENTIAL ADVERSE EVENT WITH USE OF THE BRIDGE DEVICE. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Description of Event or Problem · 0

    A PHILIPS EMPLOYEE BECAME AWARE OF A JOURNAL ARTICLE (PUBLISHED ONLINE 05APR2021) "ENDOVASCULAR OCCLUSION BALLOON-RELATED THROMBOSIS DURING TRANSVENOUS LEAD EXTRACTION". THE STUDY RETROSPECTIVELY AIMED TO EVALUATE THE INCIDENCE, PREDICTORS, AND OUTCOMES OF BALLOON-RELATED THROMBOSIS (BRT) IN PATIENTS UNDERGOING TRANSVENOUS LEAD EXTRACTION (TLE). A TOTAL OF 42 CONSECUTIVE PATIENTS UNDERGOING PROPHYLACTIC BALLOON PLACEMENT DURING TLE WERE ENROLLED IN THE STUDY. UTILIZING A SPECTRANETICS BRIDGE OCCLUSION BALLOON, TWO PROCEDURAL WORKFLOWS WERE ESTABLISHED: ONE WITH THE BALLOON WITHIN THE INFERIOR VENA CAVA DURING THE ENTIRE CASE (STANDARD COHORT) AND ONE LIMITING THE BALLOON¿S DWELL TIME (ABBREVIATED COHORT). PROCEDURAL COMPLICATIONS INCLUDED 1 FEMALE PATIENT WITH BALLOON-RELATED THROMBOSIS HAD A CLINICALLY SIGNIFICANT PULMONARY EMBOLISM (PE) ON POST-OPERATIVE DAY 3, PRESENTING WITH ACUTE ONSET OF SHORTNESS OF BREATH AND WAS INITIATED ON ORAL ANTICOAGULATION. (MDR #3007284006-2026-00226). ADDITIONALLY, 14 OTHER PATIENTS EXPERIENCED BALLOON-RELATED THROMBOSIS . ALTHOUGH GENERALIZED PATIENT INFORMATION/MEDICAL HISTORY WAS LISTED WITHIN THE JOURNAL ARTICLE, SPECIFIC PATIENT/CASE DETAIL WAS NOT PROVIDED FOR THE ADVERSE EVENTS INVOLVING THE SPECTRANETICS DEVICES. ADDITIONALLY, THE DATE OF PROCEDURE WAS NOT LISTED FOR THESE EVENTS; THEREFORE, 05APR2021 HAS BEEN USED, THE DATE OF PUBLICATION. POTHINENI, NAGA VENKATA K,- TSCHABRUNN, CORY M,CARRILLO, ROGER, SCHALLER, ROBERT D. 2021. ENDOVASCULAR OCCLUSION BALLOON-RELATED THROMBOSIS DURING TRANSVENOUS LEAD EXTRACTION. EP EUROPACE, 23(9):1472-1478. DOI:10.1093/EUROPACE/EUAB074. THIS REPORT CAPTURES THE SERIOUS INJURIES THAT OCCURRED AFTER USE OF THE BRIDGE DEVICE. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196951 BRIDGE OCCLUSION BALLOON CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN SPECTRANETICS CORPORATION 590-001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening ABBOTT VIEWFLEXTM XTRA ICE CATHETER| COOK MEDICAL BULLDOG LEAD EXTENDER| COOK MEDICAL ONE-TIE COMPRESSION COIL| ICD LEADS (MANUFACTURER, MODEL UNK)| PACING LEADS (MANUFACTURER, MODEL UNK)| SPECTRANETICS GLIDELIGHT LASER SHEATH| SPECTRANETICS LLD LEAD LOCKING DEVICE| SPECTRANETICS/PHILIPS EXCIMER LASER SYSTEM