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

Catalog Number	0052-3046
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The complainant reported that a patient was implanted with an impella device via the left femoral artery for mechanical circulatory support.It was reported that implantation of an impella cp was aborted due to patient anatomy.No patient harm was reported.
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.The cause of the difficulty to advance was determined to be patient condition related since the patient had calcium and tortuosity.
Additional Manufacturer Narrative
The cause of the difficulty to advance was determined to be patient condition related since the patient had calcium and tortuosity.

• 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 Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 25511811
• Report Number: 1220648-2026-08860
• Device Sequence Number: 10524983
• Product Code: DYB
• UDI-Device Identifier: 00813502013269
• UDI-Public: (01)00813502013269(11)251223(10)S10033664
• 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): Unknown
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0052-3046
• Device Lot Number: S10033664
• 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: 06/12/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 06/15/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2025
• 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
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White