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

Catalog Number	0052-3046
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A 58-year-old man underwent high-risk percutaneous coronary intervention (pci) with impella cp support.The pump was implanted successfully but bleeding was observed around the companion sheath after it's placement.This sheath was removed and alternate access secured to conduct the pci procedure.The sheaths were removed at the end of the case and hemostasis secured using conventional techniques.
Additional Manufacturer Narrative
A response to the request for additional information was received and noted the following: there is no further information pertaining to the case, and the impella device is not available for return.Product-specific information (e.G., d4 expiration date, d4 unique device identifier and h4 date of manufacture) is unavailable at the time of this mdr writing.Respective fields have been marked with unknown or left blank as appropriate.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
B1: added product problem, this was omitted in the initial in error.D1 and d4: updated device from companion sheath to introducer per a review of the complaint file.Corrected brand name, lot number, catalog number, udi.Added expiration date and manufacturer date.

• Brand Name: INTRODUCER
• Common Device Name: INTRODUCER, CATHETER (INTRODUCER)
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24542088
• Report Number: 1220648-2026-04695
• Device Sequence Number: 12178057
• Product Code: DYB
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2025
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0052-3046
• Device Lot Number: S9652822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 04/27/2026; 10/01/2026
• Initial Report FDA Received Date: 03/08/2026
• Supplement Report FDA Received Date: 04/28/2026; 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2025
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 233 LB
• Patient Race: White