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

Catalog Number	0052-3046
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	01/31/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
A 41-year-old male with an unknown medical history underwent percutaneous implantation of an impella cp device via the left femoral artery for temporary mechanical circulatory support.The indication for use was cardiogenic shock secondary to an acute myocardial infarction.At the time of impella initiation, the patient was classified as society for cardiovascular angiography and interventions (scai) stage c cardiogenic shock.During vascular access management, the physician performed pre-closure using perclose devices.One perclose device was successfully deployed; however, the second perclose device became stuck.The initial arterial access was noted to be in the profunda femoris artery.Imaging demonstrated vascular perforation with contrast extravasation in the groin.Balloon tamponade was attempted via contralateral access, followed by placement of two covered stents in the profunda femoris artery just distal to the bifurcation.A vascular surgeon was consulted for evaluation, and the access site was stabilized.A hematoma subsequently developed, and one unit of packed red blood cells was transfused based on observed blood loss and hemodynamic assessment.The impella sheaths were not utilized in the right common femoral artery, and the medical team elected to obtain device access via the left common femoral artery.Additional information indicated that best practices outlined in the impella instructions for use were not followed during the transition between the 14 fr sheath and the repositioning sheath.Specifically, the blue suture hub was inserted into the arteriotomy to the first ring, the sheath was peeled away while still within the groin, and recommended suture management techniques were not utilized.Contributing factors included the patient¿s concurrent use of antiplatelet and anticoagulant therapies, including aggrastat, brilinta, heparin, and aspirin.The patient remained on impella support and was reported to be in stable condition following the event.
Additional Manufacturer Narrative
H6 investigation: type, findings, and conclusion codes and h6 component codes were updated accordingly based on the completed investigation.The cause of the injury was not determined due to insufficient clinical details.

• Brand Name: KIT, 14FR INTRODUCER, 13CM&25CM, STERILE
• Common Device Name: INTRODUCER, CATHETER (SHEATH)
• 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: 24724820
• Report Number: 1220648-2026-06082
• Device Sequence Number: 21415485
• Product Code: DYB
• UDI-Device Identifier: 00813502011678
• UDI-Public: (01)00813502011678(17)280531(10)S10010850
• Combination Product (Y/N): N
• 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): 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): 03/29/2026

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: S10010850
• 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: 01/31/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2025
• 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: 41 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic