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

Catalog Number	0052-3046
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	04/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Corrected information was provided in d3 (manufacturer fax).Upon review, it was identified that it was inadvertently omitted from the initial report.Corrected information was provided in h6 (medical device problem code).Upon review, it was identified that peri-procedural adverse event was updated to patient-device interaction problem code.H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation.The root cause of the injury was unable to be determined due to insufficient clinical details.
Additional Manufacturer Narrative
A6 is unknown.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
An impella cp device was inserted via the right femoral artery in a 73-year-old female patient presenting with acute myocardial infarction complicated by cardiogenic shock (ami/cgs), with a history of diabetes mellitus.The patient¿s clinical state prior to initiation of support was identified as scai shock stage e.During support, ischemia developed in the accessed leg.The peel-away sheath was removed and a repositioning sheath was inserted without difficulty, with two preclose devices placed over a 6 f sheath.Absent pulses required reperfusion with contralateral sheaths.The patient remained on support.The ischemia may be due to access-site vascular compromise in the setting of large-bore femoral arterial cannulation and underlying critical illness.
Additional Manufacturer Narrative
Peel away was removed after angiogram revealed occlusive around peel away.Put in repo sheath and although angiogram from re-access port showed distal but sluggish flow reperfusion sheath was placed updated impacted product to the introducer as the peel away was removed after angiogram revealed occlusive around peel away.The following was updated: b5, d1, d2a, d2b, d4, and h4.
Event or Problem Description
Clinical narrative(updated): an impella cp device was inserted via the left femoral artery in a 73-year-old female patient presenting with acute myocardial infarction complicated by cardiogenic shock (ami/cgs), with a history of diabetes mellitus.The patient¿s clinical state prior to initiation of support was identified as scai shock stage e.During support, ischemia developed in the accessed leg.The peel-away sheath was removed and a repositioning sheath was inserted without difficulty, with two preclose devices placed over a 6f sheath.Angiography revealed occlusion around the peel-away sheath, which was removed.Although angiography from the reaccess port showed distal but sluggish flow, a reperfusion sheath was placed.Absent pulses required reperfusion with contralateral sheaths.The patient survived to explant.Ischemia may be due to access-site vascular compromise in the setting of large-bore femoral arterial cannulation and underlying critical illness.

• Brand Name: KIT, 14FR INTRODUCER, 13&25 CM, ABMD
• Common Device Name: INTRODUCER, CATHETER (INTRODUCER)
• 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: 24885234
• Report Number: 1220648-2026-06821
• Device Sequence Number: 9851483
• Product Code: DYB
• UDI-Device Identifier: 00813502011678
• UDI-Public: (01)00813502011678(17)280531(10)S10013971
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0052-3046
• Device Lot Number: S10013971
• 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: 04/08/2026
• Supplement Date Received by Manufacturer: 04/10/2026; 05/04/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 04/20/2026; 05/05/2026
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Hispanic