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

Catalog Number	0052-3046
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Impella cp was inserted via the 14french introducer in a 72-year-old male patient presenting with acute myocardial infarction and cardiogenic shock.The patient¿s comorbidities were not shared.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 supported by inotropes and vasopressors.The 14french introducer was used in combination with a 7french companion for a single access insertion at the right femoral.All best practices were followed for vessel access.During the insertion of the 7 french companion sheath through the 14 french sheath the hemostatic valve tore which led to a leak/bleed preventing single access.The interventional sheath was therefore moved to the contralateral leg, at the left femoral artery without noted incident.While on support the the impella cp functioned and supported for just under one day at, performance level p-7 with 2.7l/min flow with 5% dextrose in water with sodium bicarbonate in the purge solution.The device was successfully weaned and explanted.
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 ; +1(781)493-4967
• MDR Report Key: 50101724
• Report Number: 1220648-2026-11135
• Device Sequence Number: 12088691
• Product Code: DYB
• UDI-Device Identifier: 00813502013474
• UDI-Public: (01)00813502013474(17)290501(10)S10791397
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2026

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: S10791397
• 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: 07/24/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2026
• 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: 209 LB