MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 6; QEW

Catalog Number	SEP6
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat a pulmonary embolism (pe) using an indigo system separator 6 (sep6) and an indigo system aspiration catheter 8 (cat8).During the procedure, after completing two passes in the target location using the sep6 and the cat8, the physician reported that the sep6 felt different and was not breaking apart the thrombus as effectively.After removing the sep6, the bulb was found fractured.The physician performed a clinical assessment and a contrast injection under fluoroscopy and was unable to locate the bulb of the sep6 within the pulmonary vasculature.There was no report of an adverse effect to the patient.The patient remained stable post-procedure.It was also reported that the bulb of the sep6 was not visibly identified in the penumbra engine canister (canister) or the cat8.The procedure was completed using the same cat8.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

• Brand Name: INDIGO SYSTEM SEPARATOR 6
• Common Device Name: QEW
• 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 ; 5107483200
• MDR Report Key: 24612930
• Report Number: 3005168196-2026-00083
• Device Sequence Number: 10137956
• Product Code: QEW
• UDI-Device Identifier: 00814548016146
• UDI-Public: 00814548016146
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K142870
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

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: SEP6
• Device Lot Number: H00005019
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2024
• 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: 49 YR
• Patient Sex: Male