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	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical narrative: impella cp was planned for insertion via the right femoral artery in a 66-year-old male patient undergoing protected percutaneous coronary intervention (ppci).The patient¿s comorbidities were not reported.The patient¿s clinical state prior to initiation of support was not reported.During preparation for impella cp insertion, after placement of the 14 french introducer sheath, bleeding was observed from the hemostatic valve.The introducer sheath was exchanged prior to impella cp insertion.There were no reports of hemodynamic instability, transfusion requirement, blood product administration, or additional clinical complications associated with the event.Following sheath exchange, the impella cp was successfully inserted and provided circulatory support as intended.No device performance concerns were reported with the impella cp.Based on the available information, the bleeding was limited to the introducer sheath hemostatic valve and was resolved with sheath replacement.The event is conservatively reported as a device revision/replacement due to introducer sheath performance not as expected.The reported minor bleeding did not require blood products or additional intervention beyond sheath exchange.The impella cp functioned as intended following insertion, and the patient was subsequently explanted and survived.
Additional Manufacturer Narrative
The product will be returning.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.

• 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 ; +1(781)493-4967
• MDR Report Key: 50084239
• Report Number: 1220648-2026-11060
• Device Sequence Number: 10320475
• Product Code: DYB
• UDI-Device Identifier: 00813502013474
• UDI-Public: (01)00813502013474(17)280831(10)S10161554
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• 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: 0052-3046
• Device Lot Number: S10161554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male
• Patient Weight: 110 LB
• Patient Race: White