MAUDE Adverse Event Report: ABIOMED, INC. - 1220648; INTRODUCER, CATHETER (INTRODUCER)

Catalog Number	0052-3046
Medical Device Problem Codes	No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Ischemia (1942); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2026
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
Update clinical narrative: a 73-year-old male with acute myocardial infarction and cardiogenic shock (pre-support clinical state consistent with scai shock stage c) was supported with an impella cp device implanted on (b)(6) 2026 at 09:52 am and explanted on (b)(6) 2026.The impella cp was successfully explanted from the percutaneous right axillary artery using two perclose devices and one angio-seal closure device.Immediately following vascular closure and during routine follow-up angiography, acute cessation of flow was noted at the right axillary artery closure site prior to leaving the catheterization laboratory.Multiple attempts to cross the lesion with wires in order to balloon the site were unsuccessful.The implanting physician attributed the observed ischemia to the vascular closure devices (perclose and/or angio-seal).Further evaluation demonstrated persistent palpable pulses and maintained perfusion to the right arm and hand, and no worsening ischemic complications were observed.As the patient remained clinically stable with preserved extremity pulses.The patient was transferred to the intensive care unit for post-procedural management, with a plan to reassess and consider reintervention in several days if necessary.The ischemia at the site remained present without further complication.Based on the available information, this event was likely related to vascular access site closure following impella explant was the reported event appears to be related to vascular access site closure.
Additional Manufacturer Narrative
After further review the introducer had been peeled away previous to the onset of ischemia.H6 was updated he coding is being updated to no product issue.There is currently no allegation of a malfunction or serious injury associated with the implanted pump.A regulatory report is no longer necessary.Please see mfr 1220648-2026-09766 regarding pump and ischemia.

• 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 ; 7814934967
• MDR Report Key: 25135274
• Report Number: 1220648-2026-07714
• Device Sequence Number: 9324924
• Product Code: DYB
• UDI-Device Identifier: 00813502013269
• UDI-Public: (01)00813502013269(11)250815(10)S10054637
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• 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: 0052-3046
• Device Lot Number: S10054637
• 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: 05/06/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Ethnicity: Hispanic
• Patient Race: White