MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 SHEATH, 7FR SINGLE ACCESS SHEATH; INTRODUCER, CATHETER (INTRODUCER)

Catalog Number	000000000001000440
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device-specific information confirmed that the device was an abiomed companion sheath; however, no further product details (e.G., unique device identifier, lot/serial number, expiration date, or date of manufacture) were available and remain unknown.
Additional Manufacturer Narrative
The impella device will be returning for investigation.
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
The complainant reported that an impella pump was implanted via percutaneous right femoral artery for mechanical circulatory support.Oozing was noted from the hemastatic valve of the companion sheath after initial placement.The medical doctor elected to exchange for a new companion sheath.The old companion sheath was saved.The procedure was successful with the other device.No patient harm was reported.
Additional Manufacturer Narrative
The device was initially misidentified as the introducer; the correct device is the companion sheath, as reflected in d1 (brand name) and d4 (catalog number).Other product-specific information (e.G., unique device identifier, lot/serial number, expiration date, and date of manufacture) is unknown at the time of this mdr submission.Should this or any other relevant information become available, a follow-up report will be submitted accordingly.Device status.The companion sheath device was received, and evaluation/analysis is currently in progress.Accordingly, section d9 has been updated to reflect the device receipt date.Section h6 (investigation type, findings, and conclusion) has also been updated to align with this information.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.

• Brand Name: SHEATH, 7FR SINGLE ACCESS SHEATH
• 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: 24712778
• Report Number: 1220648-2026-06023
• Device Sequence Number: 6088188
• Product Code: DYB
• UDI-Device Identifier: 00813502011678
• UDI-Public: (01)00813502011678(17)280630(10)S9998663
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 000000000001000440
• Device Lot Number: S9998663
• 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: 03/20/2026
• Supplement Date Received by Manufacturer: 03/25/2026; 04/14/2026; 04/20/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/06/2026; 04/17/2026; 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2025
• 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
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 84 KG