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

Catalog Number	LITNGFHT80BER
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2023
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 left lung using an indigo system lightning flash aspiration tubing (flash tubing), an indigo system flash aspiration catheter (flash catheter), and a non-penumbra sheath.During the procedure, the physician completed multiple passes with the flash catheter and sheath.While retracting the flash catheter from inferior vena cava (ivc), the physician fractured the distal portion of flash catheter.Therefore, the proximal portion of the flash catheter was removed within the sheath.The physician advanced a different non-penumbra sheath to the ivc and used a snare device to remove the distal portion of the flash catheter.No additional information was provided.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned flash catheter confirmed a fracture on the distal end.Based on the damage at the fractured location, this fracture was likely a result of over torquing the device against resistance.If the flash catheter is over torqued against resistance during retraction, damage such as a fracture may occur.Further evaluation of the device revealed a bend on the proximal shaft.This damage was likely incidental to the complaint and may have occurred during packaging for return to penumbra.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

• 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: 18107997
• Report Number: 3005168196-2023-00503
• Device Sequence Number: 14877617
• Product Code: QEW
• UDI-Device Identifier: 00815948024861
• UDI-Public: 00815948024861
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K222358
• 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): 11/22/2023
• 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 Catalogue Number: LITNGFHT80BER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• 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: 10/15/2023
• Supplement Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 49 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005