MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA; WIRE, GUIDE, CATHETER

Model Number	GUIDE WIRE 0.018"PTFE COATED
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A4 is unknown.The impella device was not received from the customer.Therefore, the investigation of the device was not possible.Should the device or any new information be received, a supplemental report will be filed.
Event or Problem Description
The complainant reported that during impella cp insertion, the medical doctor placed a sentrant sheath and accessed the left ventricle with a pigtail.018 wire was then placed but they were unable to advance the impella catheter around the aortic arch due to heavy resistance.The medical doctor had to remove the impella cp and the guidewire together.A new impella cp was placed successfully.This report represents the guidewire.A separate report was submitted for the pump.Refer to section h.10 for the related report number.
Additional Manufacturer Narrative
The guidewire was not returned for investigation.The pump was returned for investigation with no physical damage noted.It was reported that the pump encountered heavy resistance at the aortic arch while being loaded on the 0.018 guidewire.The physician reported being unable to remove the wire, so both the device and the wire were pulled together.The cause of the removal issue was not determined, as the product was not returned and sufficient clinical information was not provided.

• Brand Name: IMPELLA
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill dr.; danvers, MA 01923 ; 7814934967
• MDR Report Key: 23309828
• Report Number: 1220648-2025-47546
• Device Sequence Number: 20117551
• Product Code: DYB
• UDI-Device Identifier: 04260113630303
• UDI-Public: (01)04260113630303(10)8854089(17)271031
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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 Model Number: GUIDE WIRE 0.018"PTFE COATED
• Device Catalogue Number: 0052-3005
• 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: 08/27/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2024
• 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: 64 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White