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

Catalog Number	CAT8XTORQ115KIT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
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 superficial femoral artery (sfa) using an indigo system aspiration catheter 8 (cat8), an indigo system separator 8 (sep8), and a non-penumbra sheath.It was reported that a thrombotic occlusion was observed in the proximal segment of the sfa and that a stent was previously placed in the middle portion of the sfa.During the procedure, the physician inserted the cat8 and sep8 into the sheath using an introducer and advanced the cat8 and sep8 to the proximal segment of the sfa.Under the fluoroscopy, the physician then noticed that the markerband was deformed prior to initiating aspiration.Therefore, the cat8 was removed.Upon removal, the physician found that the makerband was partially loosened.The procedure was completed using a new cat8 and a new sep8, and the same sheath.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa) using an indigo system aspiration catheter 8 (cat8), an indigo system separator 8 (sep8), and a non-penumbra sheath.It was reported that a thrombotic occlusion was observed in the proximal segment of the sfa and that a stent was previously placed in the middle portion of the sfa.During the procedure, the physician inserted the cat8 and sep8 into the sheath using an introducer and advanced the cat8 and sep8 to the proximal segment of the sfa.Under the fluoroscopy, the physician then noticed that the markerband was deformed prior to initiating aspiration.Therefore, the cat8 was removed.Upon removal, the physician found that the markerband was peeling off but remained intact with the cat8.The procedure was completed using a new cat8 and a new sep8, and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was updated for clarification: 1.Section b.Box 5.Describe event or problem.Evaluation of the returned indigo system aspiration catheter 8 (cat8) confirmed that the markerband was damaged.The markerband was partially peeled off and fractured.Evaluation also revealed that the polymer on the distal tip of the catheter was damaged.Operation within a previously placed stent likely contributed to polymer damage on the distal tip of the cat8 and the reported peeling of the markerband.It was reported that the markerband was intact.Therefore, the markerband fracture is incidental and occurred post-procedure.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 ASPIRATION CATHETER 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: 23031196
• Report Number: 3005168196-2025-00297
• Device Sequence Number: 9514698
• Product Code: QEW
• UDI-Device Identifier: 00815948022324
• UDI-Public: 00815948022324
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192833
• 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): 10/21/2025

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 Catalogue Number: CAT8XTORQ115KIT
• Device Lot Number: H00006279
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• 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: 7 YR
• Patient Sex: Male