MAUDE Adverse Event Report: ABIOMED, INC. - 1220648; INTRODUCER, CATHETER (INTRODUCER)

Catalog Number	0052-3025
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
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
Customer reported that the clear plastic ring on the hub of the 14fr dilator has become separated from the dilator during dilator removal from the peel away sheath.The physician has then removed the peel away sheath at the completion of the implant with the clear ring still attached.She has then separated the two in order to peel away the sheath but the clear ring has then been left over the impella catheter itself and needed to be cut off.Unclear if it was physically broken during implant or manufacturing error.There was no patient harm and the patient remains on support.
Additional Manufacturer Narrative
D6b explant date was added.
Additional Manufacturer Narrative
B5.Additional event description added.
Event or Problem Description
Additional information was received reporting the patient survived the procedure and the device was discarded.
Additional Manufacturer Narrative
Corrected information was provided in d3.Upon review, it was identified that it was inadvertently omitted from the initial report.H6 component code, type of investigation, investigation findings, and investigation conclusions codes have been updated to reflect investigation closure.The cause of pd-any device-(separation, break) was unable to be determined since product was not returned and insufficient clinical details were provided.

• Common Device Name: INTRODUCER, CATHETER (INTRODUCER)
• 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: 25059844
• Report Number: 1220648-2026-07370
• Device Sequence Number: 9353757
• Product Code: DYB
• UDI-Device Identifier: 00885672009793
• UDI-Public: (01)00885672009793(17)280131(10)S9370065
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0052-3025
• Device Lot Number: S9370065
• 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: 04/27/2026
• Supplement Date Received by Manufacturer: 05/10/2026; 05/14/2026; 07/10/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 05/12/2026; 05/18/2026; 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2025
• 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: 61 YR
• Patient Sex: Male