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

Catalog Number	CAT8XTORQ115KIT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 tibioperoneal trunk (tpt) and distal popliteal artery using an indigo system aspiration catheter 8 (cat8) and a non-penumbra sheath.During the procedure, the physician completed two passes using the cat8.Subsequently, while torquing the cat8 after aspirating the clot, the physician noticed under fluoroscopy that the cat8 was not moving and had broken in half.Therefore, the cat8 was removed along with the sheath.The procedure was completed at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned cat8 confirmed that the catheter was fractured.If the cat8 is over-rotated or torqued against resistance, damage such as a fracture may occur.Based on the reported complaint, the fracture likely occurred while subsequently torquing the cat8, with the aspirated clot.Further evaluation revealed ovalization in multiple locations along the catheter shaft.This damage was incidental to the reported complaint; however, this damage may have contributed to resistance prior to the cat8 fracturing during the procedure.Penumbra products 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 Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 16616297
• Report Number: 3005168196-2023-00132
• Device Sequence Number: 14735475
• Product Code: QEW
• UDI-Device Identifier: 00815948022324
• UDI-Public: 815948022324
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K192833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2023
• 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: 02/22/2025
• Device Catalogue Number: CAT8XTORQ115KIT
• Device Lot Number: H12620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2023
• 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: 03/01/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2022
• 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: 67 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005