MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 KIT, 14FR INTRODUCER, 13CM&25CM, STERILE; INTRODUCER, CATHETER (INTRODUCER)

Catalog Number	0052-3046
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A 66-year-old male with a pre-support clinical state consistent with scai shock stage d underwent impella cp support for high-risk percutaneous coronary intervention (hrpci).During placement of a 14f sheath via the right femoral artery, the operator reported that the sheath was inserted at a high angle with excessive force.A hematoma was noted at the access site shortly thereafter, initially presumed to be related to prior 6f sheath placement following perclose deployment.Throughout the procedure, the hematoma appeared to progressively enlarge, though visualization was limited by sterile draping.Following completion of pci, attempts to wean impella support, however the physician elected to maintain mechanical support.The 14fr peel away sheath was removed and the repositioning sheath was inserted.Upon removal of the sterile drapes, a significantly enlarged access site hematoma was identified.The decision was made to remove the impella device and transition support to an intra-aortic balloon pump (iabp) via the contralateral femoral artery.The impella device was successfully explanted, and hemostasis was managed with perclose deployment and contralateral balloon tamponade.Anticoagulation during the procedure included heparin with act maintained in the 300-second range.No vessel perforation or dissection was reported.The patient experienced access site bleeding attributed to the procedure and was reported to have survived the event.Based on available information, the access site hematoma and associated bleeding were attributed to traumatic sheath insertion involving excessive force and suboptimal insertion angle, representing a procedural complication.The event is considered procedure-related rather than device-related.
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.

• Brand Name: KIT, 14FR INTRODUCER, 13CM&25CM, STERILE
• 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 dr.; danvers, MA 01923 ; 7814934967
• MDR Report Key: 25306466
• Report Number: 1220648-2026-08196
• Device Sequence Number: 13117382
• Product Code: DYB
• UDI-Device Identifier: 00813502011678
• UDI-Public: (01)00813502011678(11)251002(10)S10143666
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0052-3046
• Device Lot Number: S10143666
• 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: 05/20/2026
• Supplement Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 07/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2025
• 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: 66 YR
• Patient Sex: Male
• Patient Race: White