MAUDE Adverse Event Report: Penumbra, Inc. Element Vascular Access Sheath; DYB

Catalog Number	ELMNT17F65
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a thrombectomy procedure in the pulmonary artery using an indigo system flash aspiration catheter (flash catheter), a penumbra engine (engine), and an element vascular access sheath (element).Aspiration thrombectomy was performed for approximately 40 minutes.Follow-up angiography demonstrated near-complete resolution of thrombus within the lower lobar arteries with improved bilateral lower lobe perfusion.Estimated blood loss was 280 ml.Immediately following the procedure, the patient developed profound hypotension with systolic blood pressure in the 50s, lactic acidosis, and acute mental status changes.The patient was treated with narcan twice and norepinephrine was initiated.Bedside echocardiography revealed a new moderate-sized pericardial effusion with cardiac tamponade.Emergent pericardiocentesis was performed, removing 240 ml of blood, and a pericardial drain was placed.Repeat computed tomography (ct) scan performed on (b)(6) 2026 showed clot burden was slightly decreased from baseline without evidence of right heart strain.Bedside echocardiography on (b)(6) 2026 demonstrated no pericardial effusion, and the pericardial drain was removed on (b)(6) 2026.Pericardial tamponade was reported to be a serious adverse event with a possible relationship to the indigo aspiration system and a possible relationship to the index procedure.The event is considered ongoing.
Additional Manufacturer Narrative
The product was not returned for evaluation.Therefore, a physical device investigation was unable to be performed.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: Element Vascular Access Sheath
• Common Device Name: DYB
• Manufacturer (Section D): Penumbra, Inc.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): Penumbra, Inc.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica menezes ; one penumbra place; alameda, CA 94502 ; +1(510)748-3200
• MDR Report Key: 50804966
• Report Number: 3005168196-2026-00307
• Device Sequence Number: 18305976
• Product Code: DYB
• UDI-Device Identifier: 00810169720073
• UDI-Public: 00810169720073
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K242520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: ELMNT17F65
• Device Lot Number: F00022463
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2026
• 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: 82 YR
• Patient Sex: Female