MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 INTRO KIT, 14FR X 13 AND 25 CM-JP; INTRODUCER, CATHETER (INTRODUCER)

Catalog Number	0052-3025-JP
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4 weight is unknown.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.
Event or Problem Description
Clinical review/rationale: an impella cp was inserted via the femoral artery to support the 75 year old male patient who had been admitted in with the indication of acute myocardial infarction and cardiogenic shock, presenting in scai stage d shock.The patient prior to the cp was supported by an intra-aortic balloon pump (iabp) and extra-corporeal membrane oxygenation (ecmo), vasopressors, inotropes, and a vent for respiratory needs.Underlying medical history was not shared.The cp was placed as care escalation from the iabp at the same access site.The site developed a hematoma that grew in size and prompted blood products, surgical suture, and pump explant.The team then had the patient supported by ecmo only.Anticoagulation necessary for the pump placement and support can contribute to access site bleeding.Patient survived the hematoma.
Additional Manufacturer Narrative
The suspect medical device was inadvertently misidentified in the initial report.Accordingly, the relevant fields in section d (suspect medical device), section g (all manufacturers), and section h (device manufacturers only) have been corrected and updated to accurately reflect the impella introducer.Note: h1.The type of reportable event and b1.Adverse event and b2.Outcomes attributed to the adverse event remain unchanged as previously reported.Additionally, complaint coding has been revised to more accurately reflect the event.As a result, the h6 health effect ¿ clinical/impact and medical device problem coding has been fully updated and should be considered the representation of the reported event.
Additional Manufacturer Narrative
Corrected information were provided in d3, d10, e1, and g1.Upon review, it was identified that these were inadvertently omitted from the initial report.H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation.The cause of bleeding issue was not determined due to insufficient clinical details and no product was returned.

• Brand Name: INTRO KIT, 14FR X 13 AND 25 CM-JP
• Common Device Name: INTRODUCER, CATHETER (INTRODUCER)
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24544788
• Report Number: 1220648-2026-04746
• Device Sequence Number: 12177947
• Product Code: DYB
• UDI-Device Identifier: 00885672009793
• UDI-Public: (01)00885672009793(17)280430(10)S9832314
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 0052-3025-JP
• Device Lot Number: S9832314
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 04/21/2026; 05/13/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/22/2026; 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EXTRACORPOREAL MEMBRANE OXYGENATION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male