MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 12; QEW

Model Number	SEP12-A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemoptysis (1887); Perforation of Vessels (2135)
Date of Event	11/16/2021
Type of Reportable Event	Death
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the pulmonary artery using an indigo system aspiration catheter 12 (cat12), lightning aspiration tubing (lightning), indigo system separator 12 (sep12), and non-penumbra catheter.During the procedure, the physician advanced a non-penumbra catheter into the pulmonary artery and injected four milligrams of tissue plasminogen activator (tpa) in both the right and left lung.Next, the cat12 was inserted into the main pulmonary artery on the left side to begin aspirating the thrombus.It was reported that the physician did not feel any resistance during advancement of the cat12 into the pulmonary artery or while aspirating in the left main medial part of the pulmonary artery using the cat12 and sep12.After a couple of minutes of aspiration, the patient began to experience hemoptysis and, therefore, the physician stopped aspiration and the patient stabilized.Subsequently, the physician performed a hand injected angiography that did not reveal any signs of trauma; however, the physician did notice infiltration in the lungs.It was also reported the cause of the infiltration of the lungs was unknown.The physician decided to end the procedure at this point and the patient was transported into an intensive care unit (icu) to recover.While in the icu, the patient started to desaturate, subsequently, upon attempting to intubate the patient, the patient began to experience more hemoptysis.Approximately an hour later, the patient expired.The relationship between the cat12 and sep12 to patient's death is unknown.The cause of the patient¿s death is unknown.
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.Potential adverse events in the labeling with the indigo aspiration system include, but are not limited to, vessel spasm, thrombosis, dissection or perforation, hematoma or hemorrhage at access site, including death.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 1.3005168196-2021-02786.

• Brand Name: INDIGO SYSTEM SEPARATOR 12
• 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: 13031216
• Report Number: 3005168196-2021-02787
• Device Sequence Number: 4416147
• Product Code: QEW
• UDI-Device Identifier: 00815948021556
• UDI-Public: 00815948021556
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K202821
• 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
• Report Date (Section B): 12/17/2021
• 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: 04/19/2024
• Device Model Number: SEP12-A
• Device Catalogue Number: SEP12
• Device Lot Number: F105578
• 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: 11/30/2021
• Initial Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2021
• 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: 68 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005