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

Model Number	GUIDE WIRE 0.018" PTFE COATED
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The guidewire was discarded by the customer and therefore,¿an evaluation of the device was not possible.Should any new information be received, a supplemental report will be filed.
Event or Problem Description
The complainant reported that a patient was implanted with an impella cp for mechanical circulatory support.Puncture and insertion of the sheath were straightforward.Placement of the 0.018 wire was uncomplicated.Threading the wire through the easy-guide lumen and positioning of the impella catheter in the left ventricle were also trouble-free.However, removing the wire from the impella cp was not possible.The 0.018 wire could not be withdrawn from the impella cp.Therefore, the decision was made to remove the impella catheter, including the 0.018 wire, from the patient via the sheath and to implant another impella cp with smartassist catheter.The patient is doing very well after the primary percutaneous coronary intervention with the second impella catheter.The patient was on a general ward and was scheduled to be discharged home in the next few days.
Additional Manufacturer Narrative
D9 updated; the device has returned for evaluation.The investigation is still ongoing.
Additional Manufacturer Narrative
Investigation summary: insertion/removal issue: the cause of the insertion/removal issue was unable to be determined as limited clinical details were provided.

• 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: 23978309
• Report Number: 1220648-2026-00206
• Device Sequence Number: 4578212
• Product Code: DQX
• UDI-Device Identifier: 04260113630303
• UDI-Public: (01)04260113630303(11)250116(10)9517924
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 02/25/2026

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
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 01/07/2026; 02/19/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 01/08/2026; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2025
• 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: 70 YR
• Patient Sex: Male