MAUDE Adverse Event Report: Abiomed, Inc. - 1220648 Kit, 14Fr Introducer, 13cm&25cm, Sterile; Introducer, Catheter (Introducer)

Catalog Number	0052-3046
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Difficult or Delayed Separation (4044)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135)
Date of Event	07/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical narratives: an impella cp device was placed via the right femoral artery in a 72 year-old male patient presenting with acute myocardial infarction complicated by cardiogenic shock (ami/cgs).The patient¿s clinical state prior to initiation of support was society for cardiovascular angiography and interventions (scai) shock stage c.The patient was additionally noted to be receiving vasopressors and inotropes for hemodynamic support.The patient¿s medical history was not reported.During the removal of the 14 french peel away sheath, bleeding was observed while splitting the sheath.It was reported that the sheath may have not been completely removed from the body prior to the splitting, which is not an abiomed recommendation, as it can contribute to vessel damage.Significant pump movement was reported during the removal process.An attempt was made to achieve hemostasis utilizing a side-closure technique with the repositioning sheath in place.A single perclose closure device was deployed.However, the sutures did not adequately engage the vessel, and the suture material was completely withdrawn from the patient while the knot was being tightened.Resistance was reported during the removal of the peel-away sheath.The patient sustained vascular damage requiring a blood transfusion of 4 units.Surgical repair was subsequently performed.The patient remained on support for an additional 3 days prior the impella device removal.The patient survived to explant with no further adverse events reported.While on support, the impella cp device operated at performance level 8 with expected flows 3.2 liters/minute.The purge solution consisted of dextrose 5% in water.The vascular damage and subsequent bleeding are most likely related to the removal of the 14 french peel-away sheath, as it was reported that the sheath may not have been completely removed from the femoral artery prior to splitting.Additional contributing factors may include the resistance encountered during sheath removal as well as significant pump movement.
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 drive; danvers, MA 01923 ; +1(781)493-4967
• MDR Report Key: 50157564
• Report Number: 1220648-2026-11326
• Device Sequence Number: 10708660
• Product Code: DYB
• UDI-Device Identifier: 00813502013474
• UDI-Public: (01)00813502013474(17)280731(10)S10129508
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• 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: S10129508
• 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: 07/25/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2025
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 180 LB
• Patient Race: White