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

Catalog Number	000000000002000342
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
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 support, the physician placed the rp flex introducer and dilator into the patient's right internal jugular vein (rij).Upon removing the dilator, the hemostatic valve did not seal.Blood was coming out of the hemostatic valve.Introducer removed over a wire and manual pressure held.New rp flex introducer and dilator were inserted into the site.New dilator removed and hemostatic valve sealed with no issue.Rp flex catheter advanced through the new introducer without issue.It was reported that the procedure was successful.
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
Correction: section e and g were inadvertently left out in the initial report which has been added in this report.Product complaint # (b)(4).Investigation summary: the pump was not returned for investigation.Data log review was not required for this case run.Fluid leak: clinical details indicate that after placing the rp flex introducer and dilator into the patient's right internal jugular vein, the hemostatic valve did not seal upon removing the dilator, resulting in blood leaking from the valve.The introducer was removed over a wire and manual pressure was applied.A new rp flex introducer and dilator were inserted, and after removing the new dilator, the hemostatic valve sealed with no issue.The cause of the fluid leak was not determined without returned product investigation and sufficient clinical details.Device history review: this introducer batch#s9732175 passed all incoming inspection checks.

• 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.; MA
• Manufacturer Contact: derek sammarco ; 22 cherry hill dr.; danvers, MA 01923 ; 7817390590
• MDR Report Key: 24114840
• Report Number: 1220648-2026-01113
• Device Sequence Number: 9697263
• Product Code: OZD
• UDI-Device Identifier: 00813502012910
• UDI-Public: (01)00813502012910(11)250814(10)S9732175
• 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: 2025
• 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: 000000000002000342
• Device Lot Number: S9732175
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2025
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White