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

Catalog Number	0052-3046
Medical Device Problem Codes	Fluid/Blood Leak (1250); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical narrative: a 39-year-old male with a history of coronary artery disease underwent high-risk percutaneous coronary intervention (hrpci) with planned impella support.The patient¿s pre-support clinical condition was consistent with scai shock stage a.The impella device and companion sheath were successfully placed percutaneously via the right femoral artery.Following placement, oozing of blood was observed originating from the center of the peel-away sheath.Upon evaluation, the physician and on-site consultant discussed potential causes, with attention to the insertion location of the companion sheath relative to the center of the peel-away valve; the needle stick was later noted to be near the center of the valve at approximately the 2 o¿clock position with an estimated insertion angle of 45 degrees.No excessive force was applied, and no vessel abnormalities were reported.To address the issue, the companion sheath was removed and additional femoral arterial access was obtained in the contralateral femoral artery.The oozing resolved following this intervention, and the procedure continued without further interruption.The impella device functioned as intended and was successfully weaned and explanted on (b)(6) 2026 at 11:45 am.Bleeding is consistent with access site complications as a result of large bore femoral procedures and the anticoagulation and purge requirements associated with impella support.It is unknown whether recommended best practices for access management were followed to mitigate the risk of bleeding.
Additional Manufacturer Narrative
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
D9.Date device returned to manufacturer added.
Additional Manufacturer Narrative
Added a01 to h6.The investigation is still ongoing.
Additional Manufacturer Narrative
H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation.Investigation summary: fluid leak / major bleed / patient-device interaction: the cause of the fluid leak was not determined since the leak was unable to be produced on the returned product.

• 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: 24981489
• Report Number: 1220648-2026-07118
• Device Sequence Number: 9480742
• Product Code: DYB
• UDI-Device Identifier: 00813502011678
• UDI-Public: (01)00813502011678(17)280229(10)S9652839
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/11/2026

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: 0052-3046
• Device Lot Number: S9652839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Supplement Date Received by Manufacturer: 04/29/2026; 05/08/2026; 06/17/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 04/30/2026; 05/11/2026; 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2025
• 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: 39 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White