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

Catalog Number	3000067
Medical Device Problem Codes	Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	No Clinical Signs, Symptoms or Conditions (4582); Hemodynamic instability (4868)
Date of Event	02/13/2026
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
Clinical rationale: an impella cp device was inserted via the right femoral artery in a 75-year-old male patient presenting with acute myocardial infarction complicated by cardiogenic shock (ami/cgs), scai shock stage c.After initial placement, removal of the placement wire resulted in a change in device position.Attempts were made to remove and reposition the device; however, resistance was encountered while withdrawing the 0.018-inch wire and the impella.The impella was advanced slightly to separate it from the sheath, and the wire was removed first, followed by the impella catheter.Inspection revealed the wire shaft was kinked.A new 0.018-inch wire was then used to successfully reposition and place the impella.The patient subsequently expired while on support.The cause of death was documented as brain-related.Per the physician, the impella was operating without issues; there were no device-related complications, and the resuscitation and subsequent decline were attributed to non-device factors consistent with a worsening brain-related condition.The reported events include difficulty removing through other device, product damage (kinked wire), medical device removal, device revision or replacement, hemodynamic instability, and death.The impella cp will be conservatively reported for death; however, the device is unlikely to have contributed to the patient¿s death, which was most likely related to the underlying brain-related condition in the setting of critical illness.
Additional Manufacturer Narrative
Corrections to the reported event were identified, and updates to the following fields were required: section h1 (type of reportable event) was updated from death to malfunction and as a result, sections b1 (adverse event/product problem), b2 (outcomes attributed) were updated.Section h6 (health effect ¿ clinical/impact) and medical device problem coding have been fully revised and are considered to accurately represent the reported event.Note: d4 (unique device identifier) was updated to blank due to uncertainty of the information at the time of this mdr writing.Upon receipt of the udi number or any additional information required for reporting, a supplemental report will be submitted accordingly.Related report numbers: this report is one of two manufacturer reports associated with the same event.A separate report for the impella cp will be submitted and cross-referenced to this report.
Additional Manufacturer Narrative
D4.Primary unique device identifier has been confirmed and updated in the field accordingly.
Additional Manufacturer Narrative
Corrected information were provided in d3, e1, e4 and g1.Upon review, it was identified that these were inadvertently omitted from the initial report.H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation.The cause of the guidewire kink was most likely use-related as resistance was felt when trying to remove the guidewire and pump together through the sheath.Based on the clinical narrative, the resistance felt during pump removal was likely a result of removing the pump and 0.018 guidewire together, and the resistance likely caused the guidewire kink.Removing the guidewire prior to removing the pump resolved the issue.

• Brand Name: GUIDEWIRE A, 0.018" PTFE, JP
• 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 (Section G): FREUDENBERG MEDICAL; 2301 centennial blvd; jeffersonville IN 47130
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24497325
• Report Number: 1220648-2026-04405
• Device Sequence Number: 16111822
• Product Code: OZD
• UDI-Device Identifier: 04260113630303
• UDI-Public: (01)04260113630303(11)241202(10)8854006
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3000067
• Device Lot Number: 8854006
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 03/25/2026; 04/02/2026; 05/13/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/03/2026; 04/03/2026; 05/15/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian