MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 PUMP 382 PUMP SET (US); TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Catalog Number	000000000001000413
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4 and a6 are unknown.The impella device was returned, and an evaluation is underway.Upon completion of our analysis, a supplemental report will be filed.
Event or Problem Description
A 77-year-old male patient presented with acute myocardial infarction complicated by cardiogenic shock (ami/cgs).The patient¿s comorbidities are unknown.Clinical assessment prior to initiation of mechanical circulatory support identified the patient as scai shock stage c.To provide hemodynamic support, an impella cp c10 device was implanted via the right femoral artery using a 14 french low profile sheath.There were no known complications during access or insertion.Post procedure, groin oozing at the access site was observed; this was effectively managed using manual pressure.There was additional bleeding beyond the access site ooze noted.The bleeding was at the patient's gums and at the foley, and so plasma blood product was infused to the patient.While on impella support, the purge solution consisted of d5w with bicarbonate.Device performance remained within the expected range for the selected support level, with reported flow at 1.9 l/min on p-4.The patient tolerated support appropriately and was successfully weaned over the course of two days, after which the impella cp c10 and associated low-profile sheath were removed.Following explant, the treating physician noted clot when aspirating the sheath.The physician expressed concern over the thrombotic burden observed and indicated this as a point of consideration for future cases involving the cp10 platform.No additional adverse events related to device function or insertion were documented.
Additional Manufacturer Narrative
H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation.Investigation summary: the cause of the major bleed was not determined since insufficient clinical details were provided.

• Brand Name: PUMP 382 PUMP SET (US)
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24579486
• Report Number: 1220648-2026-05146
• Device Sequence Number: 13345936
• Product Code: OZD
• UDI-Device Identifier: 00813502013566
• UDI-Public: (01)00813502013566(17)271130(10)2026810708
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 000000000001000413
• Device Lot Number: 2026810708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic