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

Catalog Number	2000342
Medical Device Problem Codes	Degraded (1153); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2025
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
An impella rp was placed in a seventy-two-year-old male patient for treatment of an acute myocardial infarction with associated cardiogenic shock.During femoral venous access for placement of the right-heart pump, fluoroscopy demonstrated that the guidewire was twisted.The guidewire was removed along with the twenty-three french peel-away sheath.It was then noted that the distal portion of the peel-away sheath was damaged, with clear evidence of abrasion.A second insertion kit was utilized, and the procedure proceeded.This case will be coded as a venous occlusion with device revision or replacement.
Additional Manufacturer Narrative
H6 medical device problem code a0405 was erroneously entered on the initial manufacturer device report.
Additional Manufacturer Narrative
Updated information: d6a/d6b added.
Additional Manufacturer Narrative
Corrected information was provided in d3, e4 and g2.Upon review, it was identified that these were inadvertently omitted from the initial report.H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation.The cause of introducer damage was most likely was patient condition related since the clinical team confirmed the patient had difficult anatomy of vasculature (tortuosity).

• Brand Name: KIT, 23FR INTRODUCER, 11CM, STERILE
• Common Device Name: INTRODUCER, CATHETER (SHEATH)
• 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 dr.; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24658995
• Report Number: 1220648-2026-05776
• Device Sequence Number: 9243295
• Product Code: DYB
• UDI-Device Identifier: 00813502010411
• UDI-Public: (01)00813502010411(11)240816(10)S9241387
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 03/28/2026

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: 2000342
• Device Lot Number: S9241387
• 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: 12/21/2025
• Supplement Date Received by Manufacturer: 03/19/2026; 03/30/2026; 05/26/2026
• Initial Report FDA Received Date: 03/22/2026
• Supplement Report FDA Received Date: 03/30/2026; 04/01/2026; 05/27/2026
• 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
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 105 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White