MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 KIT, 14FR INTRODUCER, 13CM&25CM, STERILE; INTRODUCER, CATHETER (INTRODUCER)

Catalog Number	0052-3046
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An impella cp was inserted via the right femoral artery in a 79-year-old male patient with acute myocardial infarction (ami) and cardiogenic shock (cgs).The patient¿s clinical state prior to initiation of support was consistent with scai stage e shock.During support, a peel away sheath was intentionally left in place per the managing physician, who had no concerns due to the patient being a bilateral below knee amputee.A small amount of oozing was noted at the insertion site, and the patient received one unit of packed red blood cells due to low hemoglobin of 7.5.The dressing around the impella remained clean and dry, with no evidence of active bleeding.The patient remained stable and survived to explant.The device was not removed due to the event.There is no evidence of device performance issues, and the pump functioned as expected throughout support.Bleeding is a known risk due to the impella's anticoagulation and purge requirements.Bleeding is listed as a potential adverse event for impella cp and is consistent with known device-related and patient-related factors described in the instructions for use (ifu).
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.
Event or Problem Description
Updated clinical rationale: an impella cp was inserted via the right femoral artery in a 79-year-old male patient with acute myocardial infarction (ami) and cardiogenic shock (cgs).The patient¿s clinical state prior to initiation of support was consistent with scai stage e shock.During support, a peel away sheath was intentionally left in place per the managing physician, who had no concerns due to the patient being a bilateral below knee amputee.A small amount of oozing was noted at the insertion site, and the patient received one unit of packed red blood cells due to low hemoglobin of 7.5.The dressing around the impella remained clean and dry, with no evidence of active bleeding.The patient remained stable and survived to explant.The field representative responded to resolve the oozing they did a proper angle matching along with using surgi seal around the insertion site of impella sheath.The device was not removed due to the event.Bleeding is a known risk due to the impella's anticoagulation and purge requirements.
Additional Manufacturer Narrative
Updated information: b5 narrative updated.
Additional Manufacturer Narrative
Corrected information was provided in d3 (manufacturer fax).Upon review, it was identified that it was 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 the access site adverse event was use related as the introducer was left in and required proper angle matching to resolve the bleeding.The cause of the injury was not determined due to insufficient clinical details.

• Brand Name: KIT, 14FR INTRODUCER, 13CM&25CM, STERILE
• Common Device Name: INTRODUCER, CATHETER (INTRODUCER)
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): OSCOR CARIBE LLC; zona franca las americas; autopista las americas km 22; santo domingo ; DO
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24300263
• Report Number: 1220648-2026-02671
• Device Sequence Number: 15993818
• Product Code: DYB
• UDI-Device Identifier: 00813502013269
• UDI-Public: (01)00813502013269(11)250527(10)S9652809
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 03/18/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0052-3046
• Device Lot Number: S9652809
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 02/28/2026; 03/28/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/18/2026; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2025
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Hispanic