MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 GUIDE WIRE 0.018"PTFE COATED; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Catalog Number	0052-3005
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
An 84 year old female with a medical history of coronary artery disease with a percutaneous coronary intervention to the left anterior descending coronary artery earlier on the same day developed de novo chest pain and st segment elevations, requiring re-evaluation in the catheterization laboratory.Placement of an impella cp was planned.While impella was being prepared for purging and connection to the controller, during preparation of the purge solution and purge cassette a "purge system failure" alarm occurred.Preparation was continued despite the alarm and the alarm eventually disappeared during next steps.The impella was then delivered into the left ventricle but the wire became stuck when trying to remove it from the pump.The system in its entirety was removed without consequences to the patient and the impella was then replaced with a new cp that could be delivered without issues.The percutaneous intervention was carried out and the new device weaned and removed successfully after the intervention.
Additional Manufacturer Narrative
Per investigator request changed pump to guidewire and ip code ¿difficult/unable to insert through other device¿ changed to ¿difficult/unable to remove through other device¿.
Additional Manufacturer Narrative
Upon review of the provided information, there is currently no allegation of a malfunction or serious injury associated with the guidewire a regulatory report is no longer necessary.

• Brand Name: GUIDE WIRE 0.018"PTFE COATED
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• 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: 24601592
• Report Number: 1220648-2026-05279
• Device Sequence Number: 15829477
• Product Code: OZD
• UDI-Device Identifier: 04260113630303
• UDI-Public: (01)04260113630303(11)241202(10)9452080
• 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,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: 0052-3005
• Device Lot Number: 9452080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 04/20/2026; 04/22/2026
• Initial Report FDA Received Date: 03/15/2026
• Supplement Report FDA Received Date: 04/22/2026; 04/27/2026
• 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: 84 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White