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

Catalog Number	LITNGFHT80BER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	03/04/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Perforation and death are included as possible complications in the instructions for use (ifu) for the indigo aspiration system.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a thrombectomy procedure left and right pulmonary artery using an indigo system flash aspiration catheter (flash catheter), a non-penumbra catheter, a neuron select catheter 6f (6f select), a non-penumbra sheath and a guide wire.It was reported that the patient was in critical status prior to the procedure.During the procedure, the physician completed four passes in the right and left lobes of the lung.While completing the fifth pass in the left lobe, the patient started coughing blood and was sat up.A rapid response team was called to resuscitate and stabilize the patient.The procedure ended at this point.A perforation in the left lobe was noted in an x-ray post procedure.The patient was then transferred to the medical intensive care unit (micu).Later, the patient expired.It was reported that the device performed as intended and that aggressive maneuvering and the fragility of the patients lungs may have contributed to the perforation.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 04/18/2024: 1.Section b.Box 2.Date of death h3 other text : placeholder.

• 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: 19028724
• Report Number: 3005168196-2024-00121
• Device Sequence Number: 12510646
• Product Code: QEW
• UDI-Device Identifier: 00815948024861
• UDI-Public: 815948024861
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 04/22/2024
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2026
• Device Catalogue Number: LITNGFHT80BER
• Device Lot Number: F00008432
• Was Device Available for Evaluation?: No
• 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: 03/04/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2023
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Date Report Sent to FDA: 01/01/2005