BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 25277475 · Received May 26, 2026

    Report

    Report Number
    1220648-2026-08154
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    May 19, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    4260113630303
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP MDR IS BEING SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION RECEIVED FROM THE SALES REPRESENTATIVE. THE SALES REPRESENTATIVE REPORTED THAT BLEEDING WAS OBSERVED FOLLOWING DEVICE INSERTION AFTER PERCLOSE DEPLOYMENT. IT WAS FURTHER REPORTED THAT UPON EXPLANT FROM THE RIGHT FEMORAL ACCESS SITE, DIFFICULTY WAS ENCOUNTERED WHEN ATTEMPTING TO RE-ADVANCE THE ABIOMED GUIDEWIRE THROUGH THE PIGTAIL AND PAST THE PROXIMAL END. THE SALES REPRESENTATIVE INDICATED THAT NON-ESSENTIAL EQUIPMENT, INCLUDING THE DEVICE, WAS DISCARDED FOLLOWING THE PROCEDURE DUE TO THE CLINICAL CIRCUMSTANCES. THE DEVICE WAS SUBSEQUENTLY EXPLANTED THE FOLLOWING DAY AND WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. RELATED MEDICAL DEVICE REPORTS: THIS IMPELLA GUIDE WIRE 0.018"PTFE COATED DEVICE REPORT IS ONE OF TWO DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER AS NOTED IN SECTION H10 FOR THE MEDICAL DEVICE REPORT ON THE IMPELLA CP.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT DURING AN IMPELLA CP PROCEDURE FOLLOWING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR), A GUIDEWIRE WAS USED TO FACILITATE DEVICE REINSERTION VIA THE LEFT FEMORAL ARTERY AFTER SWITCHING ACCESS SITES DUE TO BLEEDING FROM THE RIGHT GROIN. DURING THE REINSERTION ATTEMPT, THE ABIOMED 0.018 GUIDEWIRE WOULD NOT ADVANCE AND WAS ASSOCIATED WITH AN AUDIBLE ¿BUZZING¿ SOUND. THE IMPELLA SYSTEM WAS TEMPORARILY POWERED OFF AND THEN RESTARTED. FOLLOWING THIS, THE GUIDEWIRE WAS SUCCESSFULLY ADVANCED UNDER FLUOROSCOPIC GUIDANCE, ALLOWING FOR DEVICE PLACEMENT. SUBSEQUENT TO PLACEMENT, NO PLACEMENT SIGNAL WAS OBSERVED ON THE AUTOMATED IMPELLA CONTROLLER (AIC). NO SIGNS OR SYMPTOMS OF PATIENT INJURY OR PATIENT HARM WERE REPORTED IN ASSOCIATION WITH THIS EVENT. THIS COMPLAINT INVOLVES TWO IMPELLA DEVICES: IMPELLA CP, WITH SERIAL NUMBER 677525 IMPELLA GUIDE WIRE 0.018"PTFE COATED, WITH LOT NUMBER 9464350 THIS MDR SPECIFICALLY ADDRESSES IMPELLA GUIDE WIRE 0.018"PTFE COATED, WITH LOT NUMBER 9464350, WHICH IS THE SUBJECT OF THIS REPORT. SEPARATE MDRS WILL BE SUBMITTED FOR OTHER DEVICES ASSOCIATED WITH THIS COMPLAINT, AS APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297180 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 9464350 4260113630303

    Patients

    Seq Age Sex Outcome Treatment
    1