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

Catalog Number	LITNG7XTORQ130
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the femoral and popliteal bypass graft using an indigo system catheter 7 (cat7), a lightning aspiration tubing (lightning), and a non-penumbra sheath.It was reported that the clot burden was chronic.During the procedure, the physician completed one pass using the cat7.While torquing the cat7 through the sheath, the cat7 fractured at the midshaft.The fractured cat7 was pulled out by hand.The physician exchanged the sheath for another non-penumbra sheath.The physician then completed another pass using the second cat7.While torquing the second cat7, the physician damaged the second cat7 at the midshaft.Therefore, the second cat7 was also removed.The physician then completed eight to ten passes using the third cat7.It was reported that there were little results, and the clot burden was chronic.The third cat7 was removed.The procedure was completed using a lytic catheter.Images taken post-procedure were clear.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned indigo system cat 7 aspiration catheter (cat7) confirmed that the catheter was fractured on its proximal shaft.Evaluation revealed signs of torquing at the fracture site.If the cat7 is torqued unrestrained against resistance during advancement, damage such as a fracture may occur.Based on the reported complaint, the root cause of resistance during the procedure could not be determined.Further evaluation of the device revealed a kink on the proximal shaft.This damage is incidental to the complaint and the root cause could not be determined.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: 21952544
• Report Number: 3005168196-2025-00149
• Device Sequence Number: 8382469
• Product Code: QEW
• UDI-Device Identifier: 00815948022584
• UDI-Public: 00815948022584
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K210083
• 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): 05/02/2025

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: LITNG7XTORQ130
• Device Lot Number: H00006052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• 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 Sex: Unknown