MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 KIT, 23FR INTRODUCER, 11CM, STERILE; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Catalog Number	2000342
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
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 flex device was inserted via the right femoral vein in a (b)(6) year-old male patient.Presenting with acute myocardial infarction complicated by cardiogenic shock (ami/cgs), scai shock stage e, with a history of prior cabg, known coronary artery disease, and renal insufficiency.During placement, the hemostatic suture broke while removing the 23 fr peel-away sheath, requiring placement of a new suture while controlling active groin bleeding.A forward-tension dressing was applied, and although the catheter was noted to be very positional, bleeding was controlled.Hemoglobin remained normal.Patient survived to explant.The reported major bleed requiring surgical intervention is consistent with access-site complications and the anticoagulation/purge requirements associated with impella support.
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 this introducer batch passed all incoming inspection checks.The cause(s) of the reported bleeding (access site adverse event) was most likely use related since the clinical team confirmed the bleeding was due to the suture was broken while removing the 23fr peel-away sheath.H6 component coding and investigation type, findings and conclusion coding have been updated based on the completed investigation.Correction.D4 catalog number was corrected accordingly.

• Brand Name: KIT, 23FR INTRODUCER, 11CM, STERILE
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• 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: 24626173
• Report Number: 1220648-2026-05512
• Device Sequence Number: 18435180
• Product Code: OZD
• UDI-Device Identifier: 00813502012910
• UDI-Public: (01)00813502012910(11)241219(10)S9409333
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 2000342
• Device Lot Number: S9409333
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2024
• 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: Required Intervention
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White