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

Catalog Number	SEP8
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
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 common iliac vein using an indigo system separator 8 (sep8) and an indigo system aspiration catheter 8 (cat8).During the procedure, the physician observed under fluoroscopy imaging that the wire distal to the bulb of the sep8 had fractured inside the target vessel.The physician used a snare device to remove the wire of the sep8 from the patient.The procedure was completed using a thrombolytic catheter and the same cat8.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned indigo system separator 8 (sep8) confirmed that the separator wire distal to the bulb was fractured.If the device is repeatedly manipulated against resistance during use, the wire distal to the bulb may fracture.Based on the reported complaint, the root cause of resistance could not be determined.Further evaluation revealed kinks on the proximal end of the pusher wire.Based on the location of the damage, this may have occurred during manipulation against resistance.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: 23565036
• Report Number: 3005168196-2025-00366
• Device Sequence Number: 21400758
• 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
• Report Date (Section B): 02/04/2026

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 Expiration Date: 01/10/2026
• Device Catalogue Number: SEP8
• Device Lot Number: H00001874
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 11/15/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2023
• 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: 61 YR
• Patient Sex: Female