MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 AXILLARY INSERTION INTRODUCER; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Catalog Number	0052-3006
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A6.Race is unknown.H4.Device manufacture date is unknown.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
Clinical rationale: a 39 year old male with postcardiotomy cardiogenic shock (pccs), whose pre support clinical status was consistent with scai shock stage d, underwent placement of an impella 5.5 via the right axillary artery using a surgical graft.I was called to the or regarding a 5.5 case, and upon arrival, the implanting surgeon reported active bleeding from the introducer while the graft was clamped.A new introducer from a different 5.5 box (axillary kit) was inserted without issue.No bleeding occurred with the replacement introducer, and the procedure was successfully completed.The event involved a tip split introducer noted upon initial use, leading to bleeding at the graft site.The reported major bleed is consistent with access site complications and the anticoagulation/purge requirements associated with impella support.The device was removed and replaced without further complication.Root cause remains undetermined.When the device is returned further evaluation and analysis will be performed.The patient remains on support at the time of reporting.
Additional Manufacturer Narrative
Additionally, information was received providing the patient¿s outcome.It confirms that the impella pump used for support was explanted following successful weaning, and the patient was reported to have survived at the time of explant.
Additional Manufacturer Narrative
B5 updated.D6b updated.H6 updated with a050401 and a0207.Corrected data.A0401 removed from h6.The investigation is still ongoing.
Additional Manufacturer Narrative
Investigation summary major bleed / fluid leak: the cause of the sheath split fluid leak / bleed was not determined since product was not returned for review.Device damaged prior to use: the cause of the sheath split that was reported to come out of the package that way was unable to be determined since product was not reviewed for review and no field images were provided.
Additional Manufacturer Narrative
Updated information: b5 clinical narrative updated.D6a implant date added.
Event or Problem Description
Clinical rationale: a 39-year-old male with postcardiotomy cardiogenic shock (pccs), whose pre support clinical status was consistent with scai shock stage d, underwent placement of an impella 5.5 via the right axillary artery using a surgical graft.I was called to the or regarding a 5.5 case, and upon arrival, the implanting surgeon reported active bleeding from the introducer while the graft was clamped.A new introducer from a different 5.5 box (axillary kit) was inserted without issue.No bleeding occurred with the replacement introducer, and the procedure was successfully completed.The event involved a tip split introducer noted upon initial use, leading to bleeding at the graft site.The reported major bleed is consistent with access site complications and the anticoagulation/purge requirements associated with impella support.The device was removed and replaced without further complication.Root cause remains undetermined.When the device is returned further evaluation and analysis will be performed.The patient remains on support at the time of reporting.Update (b)(6) 2026 a separate issue of a brief controller error alarm that self resolved is being reported.No further information is available.

• Brand Name: AXILLARY INSERTION INTRODUCER
• 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 (Section G): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24620434
• Report Number: 1220648-2026-05465
• Device Sequence Number: 13302975
• Product Code: OZD
• UDI-Device Identifier: 00813502011784
• UDI-Public: (01)00813502011784(17)280331(10)S9649280
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/12/2026

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: 0052-3006
• Device Lot Number: S9649280
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 03/15/2026; 03/27/2026; 04/07/2026; 05/05/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 03/23/2026; 03/31/2026; 04/08/2026; 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 39 YR
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Ethnicity: Hispanic