MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 LAKE REGION 0.027" PTFE GUIDEWIRE; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Catalog Number	0052-3018
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Advance (2920)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4 is unknown.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
It was reported that a patient implanted with an impella rp flex experienced loss of flows.The pump was explanted and the patient was in stable condition.
Additional Manufacturer Narrative
D4 updated/corrected with the investigated product having been changed.A150206 removed from h6.Investigation summary: difficult to advance: based on the clinical details provided, the difficulty to access the pa was a result of a new tricuspid clip that was placed.Therefore, the cause of the difficult to advance was determined to most likely be due to patient condition.Major bleed: the cause of the injury was not determined due to insufficient clinical details.

• Brand Name: LAKE REGION 0.027" PTFE GUIDEWIRE
• 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: 24067204
• Report Number: 1220648-2026-00701
• Device Sequence Number: 15790443
• Product Code: OZD
• UDI-Device Identifier: 04260113630327
• UDI-Public: (01)04260113630327(11)241019(10)8854003
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 03/03/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0052-3018
• Device Lot Number: 8854003
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White