MAUDE Adverse Event Report: Abiomed, Inc. - 1220648; Temporary Non-Roller Type Left Heart Support Blood Pump

Catalog Number	0052-3025-JP
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the affected component was the introducer kit.The time of occurrence was unknown.This issue was identified during use of the impella cp pump.A 16 fr.Sheath was used.There was no patient impact.During use of the impella cp, multiple water droplets were observed around the dilator coated with silicone lubricant within the introducer kit.Water droplets were also noted on the outside of the tube covering the dilator.As a 16 fr sheath is routinely used at the facility, there was no impact on the procedure.The pump, purge cassette, and guidewire were all used without issue.The product had been stored in the catheterization laboratory under the facility's standard storage conditions.Additional information was provided which indicated that the hospital indicated that the bag had a sticky residue on it.The device was examined and found it to be slightly sticky as well.No patient harm was reported.
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.

• 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 ; +1(781)493-4967
• MDR Report Key: 50948616
• Report Number: 1220648-2026-13510
• Device Sequence Number: 10348391
• Product Code: OZD
• UDI-Device Identifier: 00885672009793
• UDI-Public: (01)00885672009793(17)280531(10)S10005555
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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 Catalogue Number: 0052-3025-JP
• Device Lot Number: S10005555
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/30/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2026
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 09/30/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2025
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 162 LB
• Patient Race: Asian