MAUDE Adverse Event Report: Abiomed, Inc. - 1220648; INTRODUCER, CATHETER

Catalog Number	0052-3046
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	09/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Product/patient demographics/indication/baseline presentation: an impella cp smartassist was inserted percutaneously via left femoral access site in 72-year-old male patient for high-risk percutaneous coronary intervention (hrpci).The patient¿s comorbidities were renal insufficiency and dialysis.The patient¿s clinical state prior to initiation of support was society for cardiovascular angiography intervention (scai) shock stage not reported.Device course & treatment: during the procedure, bleeding was observed around the 14 fr peel-away sheath site.It was reported that three vascular access attempts were required prior to sheath insertion, and vessel tenting associated with aggressive intervention was considered a potential contributing factor.The patient's hemoglobin decreased from 7.8 g/dl to 7.0 g/dl, and one unit of packed red blood cells was administered, resulting in a final hemoglobin of 7.7 g/dl.Hemostasis was successfully achieved with two perclose devices.The impella cp was explanted following completion of therapy.The patient survived the procedure and was reported with no harm.Additional factors: history of renal insufficiency and dialysis.Three vascular access attempts were required prior to sheath insertion.The patient's hemoglobin decreased from 7.8 g/dl to 7.0 g/dl.Device contribution: based on the available information, the reported bleeding event is most consistent with a procedural and/or patient-related complication associated with vascular access and multiple access attempts.No evidence was provided to suggest that the impella cp smartassist functioned improperly.A causal relationship between the device and the reported bleeding cannot be excluded.
Additional Manufacturer Narrative
Product complaint # (b)(4) 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.

• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): Abiomed, Inc. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; +1(781)493-4967
• MDR Report Key: 50947783
• Report Number: 1220648-2026-13501
• Device Sequence Number: 21207183
• Product Code: DYB
• UDI-Device Identifier: 00813502013474
• UDI-Public: (01)00813502013474(17)290701(10)S10914049
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: S10914049
• 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: 09/24/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2026
• 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: 72 YR
• Patient Sex: Male
• Patient Race: White