MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 KIT, 14FR INTRODUCER, 13CM&25CM, STERILE; INTRODUCER, CATHETER (INTRODUCER)

Model Number	KIT, 14FR INTRODUCER, 13CM&25CM, STERILE
Medical Device Problem Codes	Nonstandard Device (1420); Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2025, a 62-year-old woman arrived in cardiogenic shock with a measured ph 6.99 and a lactate level of twenty millimoles per liter, indicating a critical clinical condition.During preparation for placement of an impella cp device for hemodynamic support, it was noted that the sealed device packaging box contained an incorrect sheath.Specifically, a 23 french sheath intended for right-sided circulatory support was found instead of the required femoral arterial sheath.An additional packaging box was opened to obtain the correct femoral sheath, which resulted in a delay in initiation of device support.The event is being conservatively reported as a patient death; however, the patient¿s underlying critical condition is believed to be the most likely cause of the outcome.
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
B1 and b2: added death and death date, this was omitted in the initial report in error.B1: added product malfunction.H1: added death.H6: added code f02.H6: per a review of the complaint record, omitted code a0207 and added code a020102.
Additional Manufacturer Narrative
Defective component: the cause of defective component cannot be determined since no product was returned and insufficient clinical details were provided.

• Brand Name: KIT, 14FR INTRODUCER, 13CM&25CM, STERILE
• 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: 24370878
• Report Number: 1220648-2026-03384
• Device Sequence Number: 13211255
• Product Code: DYB
• UDI-Device Identifier: 00813502013269
• UDI-Public: (01)00813502013269(11)250407(10)S9707083
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: KIT, 14FR INTRODUCER, 13CM&25CM, STERILE
• Device Catalogue Number: 0052-3046
• Device Lot Number: S9707083
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 12/01/2025; 06/08/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/30/2026; 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2025
• 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
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White