MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 IMPELLA; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Catalog Number	0052-3046
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/18/2026
Type of Reportable Event	Malfunction
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.Related medical device reports: this 14fr introducer device report is one of two devices associated with the event.Refer to the related manufacturer report number as noted in section h10 for the medical device report on the impella cp.
Event or Problem Description
Clinical narrative: an impella cp device was inserted via the left femoral artery in a 54-year-old female patient for cardiomyopathy.The patient¿s comorbidities were unknown.The patient¿s clinical state prior to initiation of support was identified as scai shock stage c.During single access percutaneous coronary intervention (pci), blood was observed coming from between the orange piece that holds the hemostatic valve and where the orange piece connects to the peel-away sheath.Manual pressure was held on the sheath to stop the bleeding, and pci was completed.The peel-away sheath was removed and a repositioning sheath was put in place.However, due to continued bleeding from around the repositioning sheath after multiple attempts to angle-match the dressing, manual pressure was again held.A femstop was applied, and the physician elected to wean and remove the pump after about 4 hours in the icu.The pump was weaned and removed successfully, and hemostasis was achieved with two pre-close proglide sutures.The patient was hemodynamically stable upon return to the unit and survived to explant.Major bleed may be related to access-site complications and the anticoagulation and purge requirements associated with impella support, and was managed with manual compression, closure devices, and removal of the device.
Additional Manufacturer Narrative
Added d3 manufacturer fax was omitted during initial report.H6 investigation: type, findings, and conclusion codes and h6 component codes were updated accordingly based on the completed investigation.The cause of the minor bleed / fluid leak / patient device interaction was not determined due to insufficient clinical details and no product return.

• Brand Name: IMPELLA
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• 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: 24979449
• Report Number: 1220648-2026-07088
• Device Sequence Number: 13131792
• Product Code: OZD
• UDI-Device Identifier: 00813502011678
• UDI-Public: (01)00813502011678(17)280630(10)S10054635
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0052-3046
• Device Lot Number: S10054635
• 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: 04/18/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2025
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White