MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 7; QEW

Catalog Number	LITNGBT7TQ130
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left common iliac artery using an indigo system lightning bolt aspiration tubing (lightning bolt aspiration tubing), an indigo system aspiration catheter 7 (cat7), a non-penumbra sheath (7f x 10cm), a non-penumbra catheter, a non-penumbra balloon device (8x60), a glide wire (0.035), and a guidewire (0.014 300cm).During the procedure, the physician advanced the cat7 over the guidewire through the sheath and completed two passes in the previously placed stent.The physician then performed an angiogram and decided to use a non-penumbra balloon device.After ballooning, the cat7 was advanced over the guidewire to complete the next pass.Another angiogram was performed and the physician decided to place a non-penumbra stent.The cat7 was removed.While placing the stent, the physician noticed the distal portion of the cat7 was in the right iliac artery.Due to the non-availability of a snare device, the physician used a balloon device to remove the fractured portion of the cat7 without success.The patient was transferred to an outside facility for a vascular surgery to be performed.
Additional Manufacturer Narrative
The following sections are being updated based on additional information included in the user facility report submitted to the fda: 1.Section a.Box 2.Age at time of event.2.Section b.Box.5.Describe event or problem.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left common iliac artery using an indigo system lightning bolt aspiration tubing (lightning bolt aspiration tubing), an indigo system aspiration catheter 7 (cat7), a non-penumbra sheath (7f x 10cm), a non-penumbra catheter (65cm), a non-penumbra ballon device (8x60), a glide wire (0.035), and a guidewire (0.014 300cm).During the procedure, the physician advanced the cat7 over the guidewire through the sheath and completed two passes in the previously placed stent.The physician then performed an angiogram and decided to use a non-penumbra balloon device.After ballooning, the cat7 was advanced over the guidewire to complete the next pass.Another angiogram was performed and the physician decided to place a non-penumbra stent.The cat7 was removed.While placing the stent, the physician noticed the distal portion of the cat7 was in the right iliac artery.Due to the non-availability of a snare device the physician used a balloon device to remove the fractured portion of the cat7 without success.The patient was transferred to an outside facility for a vascular surgery to be performed.On 13jun2025, additional information was received that the distal portion of the cat7 was removed from the patient.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 7
• 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: 22205961
• Report Number: 3005168196-2025-00201
• Device Sequence Number: 6746682
• Product Code: QEW
• UDI-Device Identifier: 00815948025462
• UDI-Public: 00815948025462
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K223186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: LITNGBT7TQ130
• Device Lot Number: C00017191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male