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	03/27/2025
Type of Reportable Event	Malfunction
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).It was reported that the clot was not calcified but had white old thrombus.During the procedure, while performing the first pass using the cat8 and sep8, the physician felt stuck and decided to remove the sep8 from the patient.Upon removal of the sep8, the physician found that the bulb of the sep8 had fractured in the femoral vein.The cat8 was then used to aspirate the sep8 bulb.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
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned indigo system separator 8 (sep8) confirmed that the bulb was fractured.The complaint indicated that during the first pass, the sep8 felt stuck and decided to remove it.If the sep8 is retracted against resistance, damage such as a fracture may occur.Based on the reported event, the root cause of resistance could not be determined.The sep8 bulb was not returned for evaluation and was removed from the patient.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
• 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: 21882288
• Report Number: 3005168196-2025-00129
• Device Sequence Number: 12921890
• Product Code: QEW
• UDI-Device Identifier: 00815948022980
• UDI-Public: 00815948022980
• Combination Product (Y/N): Y
• 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): 05/14/2025

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: 10/23/2025
• Device Catalogue Number: SEP8
• Device Lot Number: H00001379
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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: 38 YR
• Patient Sex: Female