MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 12; QEW

Catalog Number	LITNGFB12HT100
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
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 aspiration catheter 12 (cat12), an indigo system lightning bolt aspiration tubing (lightning bolt), and a non-penumbra sheath.During the procedure, after completing 3 to 5 passes in the target location using the cat12, the physician retracted the cat12 out of the patient to perform a venogram.Upon removal of the cat12, the physician noticed that the markerband was peeling off but still intact with the cat12.Therefore, the cat12 and the lightning bolt were no longer used in the procedure.The procedure was completed using a new cat12 and a new lightning bolt.It should be noted that there were no alleged deficiency associated with the first lightning bolt.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was updated on this follow-up #01 mfr report 3005168196-2025-00417: 1.Section b.Box 5.Describe event or problem.Evaluation of the returned indigo system aspiration catheter 12 (cat12) confirmed that the distal tip was damaged.This type of damage typically occurs if the cat12 is manipulated within a stent during use.Therefore, the previously placed stent likely contributed to this damage.Evaluation revealed that the markerband was intact on the cat12.The distal tip material was not returned for evaluation.It was reported that the distal tip material was still attached to the cat12 after removal from the patient; therefore, the distal tip material likely separated from the cat12 during packaging of the device for return.Penumbra catheters are 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.Note: based on the investigation findings, this is not considered a reportable event.This event did not and, if it were to recur, it would not cause or contribute to serious deterioration or death.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat an in-stent thrombosis in the femoral vein using an indigo system aspiration catheter 12 (cat12), an indigo system lightning bolt aspiration tubing (lightning bolt), and a non-penumbra sheath.During the procedure, after completing 3 to 5 passes in the target location using the cat12, the physician retracted the cat12 out of the patient to perform a venogram.Upon removal of the cat12, the physician noticed that the distal end of the cat12 was damaged.Therefore, the cat12 and the lightning bolt were no longer used in the procedure.The procedure was completed using a new cat12 and a new lightning bolt.It should be noted that there were no alleged deficiency associated with the first lightning bolt.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 12
• 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: 23891493
• Report Number: 3005168196-2025-00417
• Device Sequence Number: 4605577
• Product Code: QEW
• UDI-Device Identifier: 00810169720011
• UDI-Public: 00810169720011
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K202821
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2026

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: LITNGFB12HT100
• Device Lot Number: H00006359
• 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: 11/28/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 02/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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: 29 YR
• Patient Sex: Female
• Patient Weight: 52 KG