MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 PURGE CASSETTE GEN 2, STERILE, NON QSK

Catalog Number	2000171
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Priming Problem (4040)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The impella device was not received from the customer, therefore, investigation of the device was not possible.Should the device or any new information be received, a supplemental mdr will be filed.
Event or Problem Description
The complainant reported that a patient was implanted with an impella cp device for mechanical circulatory support.Staff indicated that they were uncertain whether the initial purge process was initiated while the device was in the patient.
Additional Manufacturer Narrative
This follow-up report is being submitted to correct a previously reported h6 medical device problem code.The problem code a27 (appropriate device problem term/code not available) reported on the initial mdr was not applicable to the event and has been removed.

• Brand Name: PURGE CASSETTE GEN 2, STERILE, NON QSK
• Common Device Name: PURGE CASSETTE
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): ABIOMED EUROPE GMBH; neuenhofer weg 3; aachen ; GM
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24344264
• Report Number: 1220648-2026-03239
• Device Sequence Number: 9541740
• Product Code: OZD
• UDI-Device Identifier: 00813502011135
• UDI-Public: (01)00813502011135(11)250925(10)1998715
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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

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: 2000171
• Device Lot Number: 1998715
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2025
• 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
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White