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

Catalog Number	LITNGBT7TQ130
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2025
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 7 (cat7), a non-penumbra sheath and a guidewire.During the procedure, the physician completed three passes using the cat7.It was reported that the physician noted resistance while advancing the sheath prior to advancing the cat7.While torquing the cat7 through the sheath, the physician experienced resistance and decided to remove the cat7.While removing the cat7, the physician encountered resistance and noticed that the cat7 was fractured at the mid-shaft.The guidewire was advanced and the fractured cat7 was removed over the wire with the sheath.The procedure was completed using a new cat7 and a new sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned indigo system aspiration catheter 7 (cat7) confirmed that the catheter was fractured, and the distal fractured segment was stuck inside the sheath.Evaluation revealed stretching at the fractured location, indicating that the device was stretched prior to fracturing.If the cat7 is retracted against resistance, damage such as stretching and subsequent fracture may occur.Further evaluation of the non-penumbra sheath revealed kinks.The root cause of this damage could not be determined; however, this damage may have contributed to the resistance encountered during retraction of the cat7.Further evaluation revealed additional kinks on the cat7.Based on the location of the kinks, this damage is incidental to the complaint and likely occurred during packaging for return to penumbra.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.

• 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: 22311670
• Report Number: 3005168196-2025-00212
• Device Sequence Number: 15667953
• Product Code: QEW
• UDI-Device Identifier: 00815948025462
• UDI-Public: 00815948025462
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2025

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: LITNGBT7TQ130
• Device Lot Number: H00005496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2025
• Initial Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• 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: 60 YR
• Patient Sex: Unknown