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 Insert (1316); Difficult to Remove (1528); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2026
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
A 70 -year-old male patient presented with post cardiotomy cardiogenic shock.The patient¿s comorbidities are unknown.Clinical assessment prior to initiation of mechanical circulatory support identified the patient as scai shock stage c with ecmo support.The patient was status post descending artery replacement surgery on february 13th who became ill and was subsequently placed on ecmo on february 15th, after which impella was also introduced.The impella cp 10 attempted to be inserted through the 14fr low profile sheath via the left femoral artery.The device was inserted; however, positioning was not performed properly, and the 0.018 wire had slipped out of the monorail lumen, therefore the decision was made to remove the device.Due to the wire not being removed resistance was felt near the motor's entry into the sheath, so the device was pushed back and the wire was removed separately.Resistance was felt again when attempting to retract the device into the sheath without the wire, the device was pulled back, however, the coiled wire got caught near the motor, causing the device to be pulled along with the wire.Therefore, it was decided to remove the entire sheath.
Additional Manufacturer Narrative
Section d catalog number was corrected.D7a.Single-use device erroneously was blank on the initial report but should be no.
Additional Manufacturer Narrative
H6: per a review of the complaint record, omitted a0502.
Additional Manufacturer Narrative
Omitted code a150206 and added code a150207.
Additional Manufacturer Narrative
Difficult/unable to remove through other device: the cause of the initial difficulty to remove the guidewire was most likely attempting to remove the guidewire and pump together per clinical details.The guidewire was successfully removed after advancing the pump past the sheath tip.Guidewire damage was also observed on the returned product, which can likely be contributed to the significant force used during removal.

• 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: 24505187
• Report Number: 1220648-2026-04442
• Device Sequence Number: 10509917
• Product Code: OZD
• UDI-Device Identifier: 04260113630303
• UDI-Public: (01)04260113630303(11)241202(10)8854006
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,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: 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: 02/15/2026
• Supplement Date Received by Manufacturer: 03/18/2026; 03/30/2026; 04/15/2026; 05/15/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/18/2026; 04/02/2026; 04/17/2026; 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian