MAUDE Adverse Event Report: ABIOMED, INC. AXILLARY INSERTION INTRODUCER; INTRODUCER, CATHETER (INTRODUCER)

Model Number	AXILLARY INSERTION INTRODUCER
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	12/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The introducer was discarded by the customer and therefore, an evaluation of the device was not possible.Should any new information be received, a supplemental report will be filed.
Event or Problem Description
The user facility reported that a patient was implanted with an impella 5.5 for mechanical circulatory support.Bleeding was noted during arteriotomy access.Activated clotting time was used to monitor anticoagulation.Two units of blood products were given.Forward suturing was utilized.Hemostasis was achieved by surgery.The introducer was peeled away outside of the body.The repo sheath was properly placed with angle matching.The value at time of bleed was 62.9.This is one of two related reports.This report represents the introducer and another report will be submitted for the impella 5.5.
Additional Manufacturer Narrative
The root cause of the access site adverse event was not determined due to insufficient clinical details.
Additional Manufacturer Narrative
B5 clinical review/rationale was added.H10 related report was added.
Event or Problem Description
Clinical review/rationale: an impella 5.5 was inserted via right axillary artery in a 47 year old male for acute myocardial infarction with cardiogenic shock.The patient¿s comorbidities were unknown.The patient¿s clinical state prior to initiation of support was scai stage d.During arteriotomy access, bleeding was noted and the patient received 2 units of blood.It is reported that hemostasis was reported with surgery.The reported bleeding may occur in the setting of vascular access and may be influenced by patient-specific factors such as the underlying cardiogenic shock physiology, hemodynamic instability, and device position.On day 2 of support, the patient's urine output was greater than 30 cc/hr and concentrated, amber in color.On day 3 of support, the family decided to withdraw care and the patient expired.The reported hematuria may occur in the setting of purge-related anticoagulation requirements and may be influenced by patient-specific factors such as the underlying cardiogenic shock physiology, hemodynamic instability, and device position.The device is unlikely to have contributed to the patient¿s death, which was most likely related to the patient¿s underlying critical clinical condition as they presented with scai shock stage d.

• Brand Name: AXILLARY INSERTION INTRODUCER
• Common Device Name: INTRODUCER, CATHETER (INTRODUCER)
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill dr.; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 23999867
• Report Number: 1220648-2026-00261
• Device Sequence Number: 10222134
• Product Code: DYB
• UDI-Device Identifier: 00885672009755
• UDI-Public: (01)00885672009755(11)250212(10)S9408529
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 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,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 Model Number: AXILLARY INSERTION INTRODUCER
• Device Catalogue Number: 0052-3006
• Device Lot Number: S9408529
• 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: 02/10/2026; 03/04/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/11/2026; 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2025
• 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: 47 YR
• Patient Sex: Male
• Patient Weight: 180 KG
• Patient Ethnicity: Hispanic