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

Model Number	GUIDE WIRE 0.018"PTFE COATED
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4 the serial number is unknown and therefore the serial number portion was left out of the primary udi number.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 a patient in acute myocardial infarction/cardiogenic shock was implanted with an impella cp for mechanical circulatory support.When introducing the impella cp, the 0.018 guidewire was shaped and advanced into the pigtail, but it did not come out from the tip of the pigtail and encountered strong resistance.Upon checking the tip of the guidewire, a bend that had not been made during shaping was found, which was thought to be the cause.Therefore, a new wire was used, which passed through without issue and the impella cp was successfully placed.There was no harm to the patient.
Additional Manufacturer Narrative
The product was returned for investigation, and the guidewire was bend near the tip of the wire.However, the pump was not returned to determine if the pump related to the cause of resistance, and it's unclear in clinical details if the kink was present prior to advancing it through the pigtail.The cause of the guidewire kink could not be determined due to insufficient clinical details.0.018 guidewire passed all post sterile inspection criteria.

• 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 drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 22967255
• Report Number: 1220648-2025-46137
• Device Sequence Number: 9062599
• Product Code: DQX
• UDI-Device Identifier: 04260113630303
• UDI-Public: (01)04260113630303(10)8853995(17)270630
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,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
• Device Lot Number: 8853995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• 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: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian