MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 KIT, 23FR INTRODUCER, 11CM, STERILE; INTRODUCER, CATHETER (INTRODUCER)

Catalog Number	2000342
Medical Device Problem Codes	Fluid/Blood Leak (1250); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6b: the explant date is unknown.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.
Event or Problem Description
An impella rp flex was inserted via left axillary vein in a 57-year-old female who was admitted for acute myocardial infarction with cardiogenic shock.The patient¿s comorbidities were not included.The patient¿s clinical state prior to initiation of support was scai stage d.During placement, bleeding was observed from the 23fr sheath valve after the dilator removed.Bleeding is a known potential adverse event of the impella rp flex per the instructions for use.
Additional Manufacturer Narrative
Additional information.Bleeding was from the peel away sheath valve; peel away sheath was removed after insertion.
Additional Manufacturer Narrative
D6b: added explant date.
Additional Manufacturer Narrative
B5: added updated clinical review.H6: omitted a150302 and added a050401.
Event or Problem Description
An impella rp flex was inserted via left axillary vein in a 57 year old female who was admitted for acute myocardial infarction with cardiogenic shock.The patient's comorbidities were not included.The patient¿s clinical state prior to initiation of support was scai stage d.During placement, bleeding was observed from the 23fr sheath valve after the dilator removed.The team peeled away the 23fr sheath and support proceeded on the pump.Anticoagulation necessary for the pump placement and support can contribute to access site bleeding.
Additional Manufacturer Narrative
D4 and h4 updated with missing information.

• Brand Name: KIT, 23FR INTRODUCER, 11CM, STERILE
• Common Device Name: INTRODUCER, CATHETER (INTRODUCER)
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7817390590
• MDR Report Key: 24333854
• Report Number: 1220648-2026-03143
• Device Sequence Number: 21275503
• Product Code: DYB
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/22/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 2000342
• Device Lot Number: S9241387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2026
• Supplement Date Received by Manufacturer: 02/10/2026; 02/17/2026; 04/27/2026; 05/13/2026; 09/24/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 02/16/2026; 02/23/2026; 04/28/2026; 05/20/2026; 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 184 LB
• Patient Race: Black Or African American