BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRODUCER, CATHETER (SHEATH)

    MDR report key: 25044207 · Received April 30, 2026

    Report

    Report Number
    1220648-2026-07265
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    August 21, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF THREE RELATED REPORTS. THIS REPORT REPRESENTS THE SHEATH AND OTHER REPORTS WERE SUBMITTED TO REPRESENT THE IMPELLA CP AND INTRODUCER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 61-YEAR-OLD FEMALE PATIENT PRESENTING WITH HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (HRPCI), WITH A HISTORY OF KNOWN CORONARY ARTERY DISEASE, DIABETES MELLITUS, AND RENAL INSUFFICIENCY. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE B. BLEEDING WAS NOTED FROM THE COMPANION SHEATH, COMING FROM THE SHEATH ITSELF OR FROM THE 14 FR INTRODUCER SHEATH AND THEN DRIPPING OFF THE COMPANION. BLEEDING WAS ALSO NOTED FROM THE RED PLUG AT THE GREY CONNECTION OF THE PURGE SIDE ARM. THE INTERVENTIONAL CARDIOLOGIST HAD INITIAL DIFFICULTY PLACING THE COMPANION SHEATH AND SUSPECTED THE CATHETER WAS PUNCTURED BY THE MICRO PUNCTURE NEEDLE. THE CVICU WAS CALLED AND MADE AWARE THAT THE PATIENT HAD DEVELOPED A POSSIBLE GASTROINTESTINAL BLEED AND WAS TAKEN TO CT. CT REVEALED A GI BLEED AND THE PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY FOR COILING. CT ALSO REVEALED NO VASCULAR INJURY FROM THE IMPELLA SITE. THE TEAM WAS UNABLE TO FIND A PEDAL PULSE IN EITHER FOOT AND WAS UNSURE AT THE TIME IF THERE WAS LIMB ISCHEMIA. BILATERAL LOWER EXTREMITIES WERE WARM WITH GOOD CAP REFILL. THE TEAM RECONSULTED VASCULAR SURGERY TO DETERMINE IF INTERVENTION WAS NEEDED. CLINICAL CONTACTS WERE GIVEN. THE PATIENT REMAINED INTUBATED OVERNIGHT, AND THE TEAM WAS WEANING VASOPRESSORS AS ABLE. THE GI BLEED WAS ASSOCIATED WITH THE GASTROEPIPLOIC ARTERY. THE NURSE LATER REPORTED THAT DISTAL PULSES IN BOTH LEGS COULD BE DETECTED BY DOPPLER. THE PLAN WAS TO ATTEMPT TO WEAN DRIPS AS THE PATIENT TOLERATED. THE PUMP WAS REMOVED DUE TO BLEEDING FROM THE PURGE SIDE ARM, POSSIBLY RELATED TO A STICK TO THE CATHETER WITH MICRO PUNCTURE FOR PLACING THE COMPANION SHEATH, AND REPLACED WITH A SECOND CP. THE PATIENT SURVIVED TO EXPLANT. BLEEDING MAY BE RELATED TO ACCESS-SITE COMPLICATIONS, ANTICOAGULATION REQUIREMENTS, AND PROCEDURAL FACTORS SUCH AS MICRO PUNCTURE NEEDLE INJURY AND UNDERLYING CRITICAL ILLNESS. LIMB ISCHEMIA MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS PERIPHERAL VASCULAR DISEASE, CRITICAL ILLNESS, HEMODYNAMIC INSTABILITY, AND VASCULAR ACCESS CHARACTERISTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420749 INTRODUCER, CATHETER (SHEATH) DYB ABIOMED, INC. - 1220648

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention