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

Catalog Number	0052-3009
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	03/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An impella 5.5 device was inserted via the right axillary artery in a 34-year-old female patient presenting with acute myocardial infarction complicated by cardiogenic shock (ami/cgs), scai shock stage e.The patient¿s comorbidities were unknown.A graft was sewn onto the right axillary artery, and the sheath and graft were secured in place.During the procedure, the surgeon attempted to advance a 0.035-inch j-wire but was unable to pass it through the anastomosis.The anastomosis was taken down, at which time dissection of the axillary artery was identified.A patch was placed to repair the artery, and a 10 mm graft was subsequently anastomosed to the patch.The patient remained on impella support following the repair.The reported vascular dissection is consistent with access-related arterial injury during surgical manipulation and graft anastomosis in the setting of urgent mechanical circulatory support placement.
Additional Manufacturer Narrative
D6b: explant date 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.
Additional Manufacturer Narrative
D6b updated.The investigation is still ongoing.
Additional Manufacturer Narrative
G1 corrected the manufacturer contact phone number.H6 investigation type and findings codes and h6 component codes were updated accordingly based on the completed investigation.The cause of the patient device interaction could not be determined as insufficient clinical details were provided.The cause of the difficulty to advance could not be determined as limited clinical details were provided.
Additional Manufacturer Narrative
B1 product problem was inadvertently omitted on the initial manufacturer device report.H6 medical device problem code a24 omitted.A150205 and a01 added.

• Brand Name: INTRODUCER
• 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: 24754145
• Report Number: 1220648-2026-06247
• Device Sequence Number: 15760597
• Product Code: DYB
• UDI-Device Identifier: 00813502010015
• UDI-Public: (01)00813502010015(11)250828(10)1998425
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/06/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0052-3009
• Device Lot Number: 1998425
• 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: 03/25/2026
• Supplement Date Received by Manufacturer: 04/05/2026; 04/20/2026; 05/22/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 04/06/2026; 04/23/2026; 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2025
• 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: 34 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Race: White