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

Catalog Number	CAT8XTORQ115KIT
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
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), a non-penumbra sheath (8f), and a.035 guidewire.It was reported that a non-penumbra stent was previously placed in the sfa, and that thrombotic occlusion was observed along the entire length of the stent.During the procedure, the cat8 and sep8 were advanced through the sheath and into the in-stent and aspiration was initiated.The physician completed two passes using the cat8 and sep8 and noticed that the marker band on the distal end of the cat8 came off.Therefore, the cat8 and sep8 were removed.It was reported that while aspirating, the stent would temporarily deform due to the aspiration force but returned to normal when the aspiration stopped.The physician then advanced a new cat8 and sep8 into the in-stent using the same sheath and initiated aspiration to remove the detached marker band and thrombus.After completing one pass, the physician noticed that the marker band on the distal end of the second cat8 came off as well.Therefore, the cat8 and sep8 were removed.The physician then decided to perform an open surgery to remove the detached marker bands with biopsy forceps and to remove the thrombus with a non-penumbra catheter.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.This report is associated with mfr report number: (b)(4).
Additional Manufacturer Narrative
Please note that the following section was updated: 1.Section b.Box 5.Describe event or problem.Evaluation of the returned cat8 confirmed that the markerband was detached from the catheter and revealed that the distal tip of the cat8 was damaged.Operation within the stent may have contributed to the damage to the distal tip of the cat8.The distal tip damage likely caused the markerband to detach from the catheter during the procedure.Further evaluation of the device revealed bends along the catheter shaft.This damage was incidental to the complaint and likely occurred during packaging for return to penumbra.Penumbra devices 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.This report is associated with mfr report number: 1.3005168196-2024-00291 h3 other text : placeholder.
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), a non-penumbra sheath (8f) and a.035 guidewire.It was reported that a non-penumbra stent was previously placed in the sfa, and that thrombotic occlusion was observed along the entire length of the stent.During the procedure, the cat8 and sep8 were advanced through the sheath and into the stent and aspiration was initiated.The physician completed two passes using the cat8 and sep8 and noticed that the markerband on the distal end of the cat8 came off.Therefore, the cat8 and sep8 were removed.It was reported that while aspirating, the stent would temporarily deform due to the aspiration force but returned to normal when the aspiration stopped.The physician then advanced a new cat8 and sep8 into the stent using the same sheath and initiated aspiration to remove the detached markerband and thrombus.After completing one pass, the physician noticed that the markerband on the distal end of the second cat8 came off as well.Therefore, the cat8 and sep8 were removed.The physician then decided to perform an open surgery to remove the detached markerbands with biopsy forceps and to remove the thrombus with a non-penumbra catheter.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), a non-penumbra sheath, and a.035 guidewire.It was reported that a non-penumbra stent was previously placed in the sfa, and that thrombotic occlusion was observed along the entire length of the stent.During the procedure, the cat8 and sep8 were advanced through the sheath and into the stent and aspiration was initiated.The physician completed two passes using the cat8 and sep8 and noticed that the markerband on the distal end of the cat8 came off.Therefore, the cat8 and sep8 were removed.It was reported that while aspirating, the stent would temporarily deform due to the aspiration force but returned to normal when the aspiration stopped.The physician decided to place a new stent within the existing stent.After deploying the new stent, a new cat8 and sep8 were advanced through the stents using the same sheath, and aspiration was initiated to remove the detached markerband and thrombus.After completing one pass, the physician noticed that the markerband on the distal end of the second cat8 came off as well.Therefore, the cat8 and sep8 were removed.The physician then decided to perform an open surgery to remove the detached markerbands with biopsy forceps and to remove the thrombus with a non-penumbra catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by penumbra clinical team: section b.Box 5.Describe event or problem.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra distributor on 8/20/2025.Section b.Box 5.Describe event or problem.
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), a non-penumbra sheath, and a.035 guidewire.It was reported that a non-penumbra stent was previously placed in the sfa, and that thrombotic occlusion was observed along the entire length of the stent.During the procedure, the cat8 and sep8 were advanced through the sheath and into the stent and aspiration was initiated.The physician completed two passes using the cat8 and sep8 and noticed that the markerband on the distal end of the cat8 came off.Therefore, the cat8 and sep8 were removed.It was reported that while aspirating, the stent would temporarily deform due to the aspiration force but returned to normal when the aspiration stopped.The physician decided to place a new stent within the existing stent.After deploying the new stent, a new cat8 and sep8 were advanced through the stents using the same sheath, and aspiration was initiated to remove the detached markerband and thrombus.After completing one pass, the physician noticed that the markerband on the distal end of the second cat8 came off as well.Therefore, the cat8 and sep8 were removed.The physician then performed a cut-down at the initial access site and used biopsy forceps to remove the detached markerbands from the sfa.The procedure was completed using a non-penumbra catheter.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 8
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 20066235
• Report Number: 3005168196-2024-00292
• Device Sequence Number: 15563464
• 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,Followup,Followup
• Report Date (Section B): 09/18/2025
• Report Date (Section F): 01/01/2005

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: 01/12/2026
• Device Catalogue Number: CAT8XTORQ115KIT
• Device Lot Number: H00001919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2024
• Supplement Date Received by Manufacturer: 09/11/2024; 05/11/2025; 08/20/2025
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 10/08/2024; 06/10/2025; 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2023
• 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: 66 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005