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

Catalog Number	0052-3046
Medical Device Problem Codes	Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The complainant reported a patient was implanted with an impella device for mechanical circulatory support.During implant, a long sheath was utilized.The physician attempted to advance the impella up the descending aorta and was unable.The sheath kinked.An aortogram was performed, showing plaque burden in descending where the impella was getting stuck.No issues putting pigtail and wire in (left ventricle) lv prior to the impella.Decision made to abort procedure.
Additional Manufacturer Narrative
The impella device was not received from the customer; therefore, investigation of the device was not possible.Should the device or any new information be received, a supplemental mdr will be filed.
Additional Manufacturer Narrative
The device was not returned; therefore, evaluation and analysis could not be performed.A device history record review was conducted and confirmed the device passed all incoming inspection checks.The cause(s) of the reported failure to advance was determined to be patient condition as the patient had plaque and calcification of vessels preventing successful delivery of impella.Regarding the kink, the cause was determined to be patient condition as well as the patient had plaque and calcification of vessels.H6 component coding and investigation type, findings and conclusion coding have been updated based on the completed investigation.Correction: section e1 (initial reporter) was not fully populated in the initial report.This section has now been updated and completed to include all required information.Correction: the g1 manufacturing site name and address provided in the initial report was entered incorrectly.These fields should reflect the same information as g1 manufacturer contact name, facility, and address.

• Brand Name: INTRODUCER
• Common Device Name: INTRODUCER, CATHETER (INTRODUCER)
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): OSCOR CARIBE LLC; zona franca las americas; autopista las americas km 22; santo domingo ; GM
• Manufacturer Contact: derek sammarco ; 22 cherry hill dr.; danvers, MA 01923 ; 7817390590
• MDR Report Key: 24292824
• Report Number: 1220648-2026-02593
• Device Sequence Number: 9408172
• Product Code: DYB
• UDI-Device Identifier: 00813502013269
• UDI-Public: (01)00813502013269(11)250131(10)S9557224
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 0052-3046
• Device Lot Number: S9557224
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2025
• 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: 75 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White