MAUDE Adverse Event Report: OSCOR, INC. - 1035166 AXILLARY INSERTION INTRODUCER; INTRODUCER, CATHETER (INTRODUCER)

Catalog Number	0052-3006
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Codes	No Clinical Signs, Symptoms or Conditions (4582); Hemodynamic instability (4868)
Date of Event	02/17/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
This follow-up report is being submitted to update sections b1, b2, b5, h1, and h6 based on new information received indicating that the patient has expired.B1: updated to include adverse event.B2: updated to include death and the date of death.B5: updated to incorporate new clinical information that was not included in the initial submission.The revised b5 now contains a complete and accurate event narrative.H1.Type of reportable event: corrected from the previous classification to death.H6.Health effect - clinical code: code e2403 (no clinical signs, symptoms, or conditions) has been removed and replaced with e2343 (hemodynamic instability) to reflect newly reported clinical findings.Health effect - impact code: code f26 (no health consequences or impact) has been removed and replaced with f02 (death) to accurately represent the outcome.All other information previously reported remains unchanged.
Event or Problem Description
Clinical rationale: an impella 5.5 device was inserted via the right axillary artery in a 61-year-old male patient presenting with acute myocardial infarction complicated by cardiogenic shock (ami/cgs), scai shock stage d.There were graft locks and resistance noted along the peel-away sheath.Care was later withdrawn, and the patient subsequently expired.The mechanical issue had no impact on the patient¿s hemodynamics.The device will be conservatively reported for death; however, the device is unlikely to have contributed to the patient¿s death and is most likely attributed to the patient¿s underlying critical clinical condition, as they presented in scai shock stage d.
Additional Manufacturer Narrative
A4 weight and a6 race are 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
The complainant reported an issue involving an impella sheath and insertion kit during a clinical procedure.Specifically, difficulties were reported with the graft lock and the peel-away sheath during use.The procedure was completed successfully, and the patient experienced no harm.

• Brand Name: AXILLARY INSERTION INTRODUCER
• Common Device Name: INTRODUCER, CATHETER (INTRODUCER)
• Manufacturer (Section D): OSCOR, INC. - 1035166; 3816 desoto boulevard; palm harbor FL 34683
• 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: 24457556
• Report Number: 1220648-2026-04130
• Device Sequence Number: 13114380
• Product Code: DYB
• UDI-Device Identifier: 00885672009755
• UDI-Public: (01)00885672009755(11)250528(10)S9834144
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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

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: 0052-3006
• Device Lot Number: S9834144
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/03/2026
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic