BEUDAMED
    FDA Adverse Event Death Summary report: N

    EMERGE?

    MDR report key: 23181899 · Received September 30, 2025

    Report

    Report Number
    2124215-2025-66332
    Event Type
    Death
    Date Received
    September 30, 2025
    Date of Event
    August 29, 2025
    Report Date
    October 31, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729806417
    PMA / PMN Number
    K113220
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K): K163174.

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER EMAIL UPDATED. G4: PREMARKET/510(K): K163174.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT DIED. THE PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE TARGETING BOTH THE LEFT ANTERIOR DESCENDING (LAD) AND THE RIGHT CORONARY ARTERY (RCA). DURING TREATMENT OF A LONG, MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE RCA, A 2.50 MM X 30 MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. AT THE BEGINNING OF THE THIRD INFLATION, THE BALLOON RUPTURED AT A PRESSURE OF LESS THAN 14 ATM. FOLLOWING THE RUPTURE, NO BLOOD FLOW IN THE RCA AND THE PATIENT EXPERIENCED A BRIEF ASYSTOLIC EPISODE. THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE, HOWEVER, ONLY THE CATHETER SHAFT WAS RETRIEVED. THE FULL 30 MM BALLOON MATERIAL REMAINED INSIDE THE PATIENT AND WAS NOT VISIBLE ON ANGIOGRAPHY. THE PHYSICIAN PROCEEDED TO PLACE STENT IN THE RCA TO RESTORE BLOOD FLOW, WHICH WAS SUCCESSFULLY RE-ESTABLISHED. THE PATIENT WAS STABLE POST-PROCEDURE AND WAS DISCHARGED THE SAME DAY. TWO DAYS POST-DISCHARGE, THE PATIENT RETURNED TO THE HOSPITAL IN A WORSENED CONDITION. A DIAGNOSTIC CORONARY ANGIOGRAPHY REVEALED A COMPLETE OCCLUSION OF THE RCA, WHICH COULD NOT BE RE-OPENED. THE PATIENT SUBSEQUENTLY PASSED AWAY, WITH CARDIAC FAILURE LISTED AS THE OFFICIAL CAUSE OF DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT DIED. THE PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE TARGETING BOTH THE LEFT ANTERIOR DESCENDING (LAD) AND THE RIGHT CORONARY ARTERY (RCA). DURING TREATMENT OF A LONG, MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE RCA, A 2.50 MM X 30 MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. AT THE BEGINNING OF THE THIRD INFLATION, THE BALLOON RUPTURED AT A PRESSURE OF LESS THAN 14 ATM. FOLLOWING THE RUPTURE, NO BLOOD FLOW IN THE RCA AND THE PATIENT EXPERIENCED A BRIEF ASYSTOLIC EPISODE. THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE, HOWEVER, ONLY THE CATHETER SHAFT WAS RETRIEVED. THE FULL 30 MM BALLOON MATERIAL REMAINED INSIDE THE PATIENT AND WAS NOT VISIBLE ON ANGIOGRAPHY. THE PHYSICIAN PROCEEDED TO PLACE STENT IN THE RCA TO RESTORE BLOOD FLOW, WHICH WAS SUCCESSFULLY RE-ESTABLISHED. THE PATIENT WAS STABLE POST-PROCEDURE AND WAS DISCHARGED THE SAME DAY. TWO DAYS POST-DISCHARGE, THE PATIENT RETURNED TO THE HOSPITAL IN A WORSENED CONDITION. A DIAGNOSTIC CORONARY ANGIOGRAPHY REVEALED A COMPLETE OCCLUSION OF THE RCA, WHICH COULD NOT BE RE-OPENED. THE PATIENT SUBSEQUENTLY PASSED AWAY, WITH CARDIAC FAILURE LISTED AS THE OFFICIAL CAUSE OF DEATH. IT WAS FURTHER REPORTED THAT THE PHYSICIAN ATTEMPTED RETRIEVAL USING A LASSO, A STANDARD TECHNIQUE FOR FOREIGN BODY EXTRACTION, THOUGH THE EFFORT WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1672685 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493918930250 0035960402 08714729806417

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Death| R