MAUDE Adverse Event Report: ABIOMED, INC. OSCOR INTRO KIT, 14FR X 13 AND 25 CM; INTRODUCER, CATHETER (INTRODUCER)

Model Number	OSCOR INTRO KIT, 14FR X 13 AND 25 CM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	12/30/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
D4.Lot number, serial number, expiration date and h4.Device manufacture date are unknown.The impella device was not received from the customer, therefore, investigation of the device was not possible.Should the device or any new information be received, a supplemental mdr will be filed.
Event or Problem Description
The complainant reported that doppler signals were not detected in the patient¿s left foot.The patient subsequently expired.
Additional Manufacturer Narrative
Investigation summary: no product was returned.Ppae (ischemia): in order to make a cause determination, all of the clinical details outlined in es2023-0158 would have to be provided.The root cause of the injury was unable to be determined due to insufficient clinical details.Device history lot: device lot: s9607283.Device history batch: subcomponent lot: n/a.Device history review: 14 fr introducer batch#: s9607283 passed all incoming inspection checks.

• Brand Name: OSCOR INTRO KIT, 14FR X 13 AND 25 CM
• Common Device Name: INTRODUCER, CATHETER (INTRODUCER)
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 23999998
• Report Number: 1220648-2026-00299
• Device Sequence Number: 18772405
• Product Code: DYB
• UDI-Device Identifier: 00860001797916
• UDI-Public: (01)00860001797916(11)250806(10)S9607283
• 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: 2025
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 01/27/2026

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 Model Number: OSCOR INTRO KIT, 14FR X 13 AND 25 CM
• Device Catalogue Number: 0052-3025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Death
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Race: Black Or African American