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

Catalog Number	LITNGFXT100H1
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
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 underwent a thrombectomy procedure in the iliac vein using an indigo system flash aspiration catheter (flash catheter) and a non-penumbra sheath.During the procedure, the physician made approximately five to six passes in the target location using the flash catheter.It was reported the physician was experiencing resistance while advancing the flash catheter through a previously placed stent that had collapsed.After successfully aspirating in the vessel, the physician removed the flash catheter and noticed the distal end of the flash catheter was damaged.The procedure had ended at this point and no additional device was needed to complete the procedure.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned flash catheter confirmed that the distal tip was damaged.Evaluation revealed that the markerband was detached from the distal tip.If the flash catheter is manipulated within a collapsed stent, resistance may be encountered during use.The interaction between the catheter and collapsed stent likely caused the distal tip damage noticed during removal.Based on the reported event, the markerband was damaged but attached after removal from the procedure.The markerband was later detached from the distal tip of the catheter.Further evaluation revealed scratches to the distal end of the catheter.This damage likely also occurred due to interactions with the stent but was incidental to the reported complaint.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 FLASH ASPIRATION CATHETER
• 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: 20669580
• Report Number: 3005168196-2024-00384
• Device Sequence Number: 20654382
• Product Code: QEW
• UDI-Device Identifier: 00815948029866
• UDI-Public: 00815948029866
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K222358
• 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,Followup
• Report Date (Section B): 11/27/2024
• 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 Catalogue Number: LITNGFXT100H1
• Device Lot Number: F00012654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2024
• 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: 10/18/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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: 57 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005