MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 AXILLARY INSERTION KIT; INTRODUCER, CATHETER (INTRODUCER)

Catalog Number	0052-3009
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An impella 5.5 was placed via the axillary access graft site for the support of a 66 year old female patient who had been admitted in with cardiomyopathy and cardiogenic shock, presenting in scai stage d shock.The patient was on inotropes and vasopressors and a vent for respiratory needs.The 5.5 position was confirmed by imaging and the sheath was removed and the pocket was closed.After 10-15 minutes of support she experienced hypotension and the surgical team re-imaged with tee echo to observe there was an effusion.The team performed a pericardial window to drain and the bleed persisted so, team lifted her heart and this revealed there was a large defect in the left atrium.The attempted surgical repair and transfusion, but this failed and the patient expired.The team did acknowledge that the patient had multiple ablations prior to the effusion and left atrium defect, which could have been a contributing factor.The death is conservatively being reported although an unlikely contributing factor to the death, and more likely the patient's presenting native critical condition as presented in scai stage d.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
The complaint occurred after introducer was removed.This record will be closed as non-product issue (npi).After evaluation, the complaint does not meet the criteria for mdr reportability as defined by 21 cfr 803.50.

• Brand Name: AXILLARY INSERTION KIT
• Common Device Name: INTRODUCER, CATHETER (INTRODUCER)
• 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: 24387617
• Report Number: 1220648-2026-03542
• Device Sequence Number: 10567752
• Product Code: DYB
• UDI-Device Identifier: 00813502013269
• UDI-Public: (01)00813502013269(11)250904(10)2000967
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: 0052-3009
• Device Lot Number: 2000967
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2025
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White