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

Model Number	KIT, 14FR INTRODUCER, 13CM&25CM, STERILE
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	02/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An impella cp was inserted via left femoral artery in a 62 year old female who was admitted for high risk percutaneous coronary intervention.The patient¿s comorbidities were coronary artery disease and diabetes mellitus.The patient¿s clinical state prior to initiation of support was scai stage c.The patient received support with the cp for the coronary angioplasty.At the end of the procedure, the cp was explanted and left femoral site was closed with perclose x2.An angiogram revealed a lesion at the left femoral access site requiring balloon angioplasty of left superficial femoral artery.Ballooning was successful with distal runoff.Bleeding and vascular injury are known potential adverse events of the impella cp per the instructions for use.
Additional Manufacturer Narrative
The impella device has not been received from the customer, therefore, investigation of the device has not been possible.Should the device or any new information be received, a supplemental mdr will be filed.
Additional Manufacturer Narrative
E4 was inadvertently omitted on the initial manufacturer device report.The impella device was returned, and an evaluation is underway.Upon completion of our analysis, a supplemental report will be filed.
Additional Manufacturer Narrative
D3 (manufacturer fax) has been added.G2 ( is report source company rep) has been ticked.H3 (device evaluated by manufacturer?) has been updated.Major bleed/access site adverse event: the cause of major bleed/access site adverse event was unable to be determined as limited clinical details were provided and no issue was found on the pump & introducer.

• Brand Name: KIT, 14FR INTRODUCER, 13CM&25CM, STERILE
• Common Device Name: INTRODUCER, CATHETER (SHEATH) PROPRIETARY
• 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 dr.; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24294712
• Report Number: 1220648-2026-02612
• Device Sequence Number: 9332621
• Product Code: DYB
• UDI-Device Identifier: 00813502013269
• UDI-Public: (01)00813502013269(11)250623(10)S9913597
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2026

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 Model Number: KIT, 14FR INTRODUCER, 13CM&25CM, STERILE
• Device Catalogue Number: 0052-3046
• Device Lot Number: S9913597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 02/09/2026; 04/03/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 02/11/2026; 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White