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	08/02/2025
Type of Reportable Event	Death
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.
Event or Problem Description
On (b)(6) 2025, the patient was undergoing a thrombectomy procedure for pulmonary embolism in the bilateral pulmonary arteries using a catheter (pigtail), guidewire, and an element vascular access sheath (element sheath).During the procedure, the physician advanced the guidewire and catheter but was unaware that the guidewire and catheter were positioned in the pericardium.The physician then inserted the element sheath over the guidewire.At this time, the patient decompensated, and a code blue was initiated.During resuscitation efforts, the patient was administered tissue plasminogen activator (tpa); however, the patient subsequently expired.On 12-aug-2025, the penumbra representative received information that during an imaging review in the days following the procedure, it was determined that the guidewire perforated the pericardium.

• 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 farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 22911035
• Report Number: 3005168196-2025-00276
• Device Sequence Number: 13057460
• Product Code: DYB
• UDI-Device Identifier: 00810169720073
• UDI-Public: 00810169720073
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

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: F00015012
• 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: 08/02/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2025
• 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; Death
• Patient Age: 57 YR
• Patient Sex: Male