MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 8; QEW

Catalog Number	SEP8
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the femoral vein using an indigo system separator 8 (sep8) and an indigo system aspiration catheter 8 (cat8).During the procedure, the physician felt resistance while advancing the sep8 during the first pass and decided to remove it.After retracting the sep8 out of the patient, the physician found that the wire distal to the bulb of the sep8 was fractured but still connected by a wire.The procedure was completed using a new sep8 and the same cat8.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were inadvertently missed on the initial mfr report and are being updated on this follow-up.#01 mfr report 3005168196-2025-00187: 1.Section a.Box 1.Patient identifier.2.Section a.Box 2.Age at time of event.3.Section a.Box 3.Sex.
Additional Manufacturer Narrative
Evaluation of the returned indigo system separator 8 (sep8) confirmed that the separator wire distal to the bulb was fractured.Evaluation revealed that the separator bulb was fractured on its distal end, the core wire was fractured distal to the bulb, and the coil wrapping wires were unraveled.If the sep8 is manipulated against resistance, damage such as a fracture may occur.Based on the reported complaint, the root cause of resistance during the procedure could not be determined.Further evaluation of the returned sep8 revealed damage on the orange distal length.This damage was incidental to the reported complaint and the root cause could not be determined.Penumbra devices are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: INDIGO SYSTEM SEPARATOR 8
• 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 farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 22128541
• Report Number: 3005168196-2025-00187
• Device Sequence Number: 8391648
• Product Code: QEW
• UDI-Device Identifier: 00815948022980
• UDI-Public: 00815948022980
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K161523
• 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,Followup
• Report Date (Section B): 07/09/2025

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 Expiration Date: 08/22/2025
• Device Catalogue Number: SEP8
• Device Lot Number: H00001004
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: Not provided; 06/27/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/03/2025; 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• 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: 67 YR
• Patient Sex: Female