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

Catalog Number	SEP12
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	10/13/2022
Type of Reportable Event	Death
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat bilateral pulmonary embolism using an indigo system cat12 aspiration catheter (cat12), an indigo system separator 12 (b)(6) 2022, a non-penumbra sheath and guidewires.During the procedure, the physician advanced the cat12 over the guidewire to the face of the clot.The physician then removed the guidewire, introduced the sep12 and started aspiration.Within the first minute of aspiration, the patient began coughing up blood.Therefore, the physician stopped aspiration and noticed through an angiogram a perforation in the pulmonary artery.Subsequently, the physician removed the cat12 and the (b)(6) 2022.The procedure was aborted at this point and the patient was placed on ecmo.A balloon was put in the pulmonary artery to stop the bleeding and the next day, the patient underwent a thrombectomy procedure in the right pulmonary artery using a non-penumbra device.It was reported that the patient was doing better and was slowly weaned off ecmo.It was also reported that the physician believed that the perforation of the vessel occurred during insertion of the sheath and could not be attributed to any penumbra devices used in the procedure.The physician also mentioned that the guidewire used was buckling in the left pulmonary artery''s lower lobe prior to the cat12 being introduced.On (b)(6) 2022, it was reported that the patient expired.On (b)(6) 2022, we received an update indicating that the site determined the left pulmonary artery hemorrhage is possibly related to indigo devices and definitely related to the index procedure.
Additional Manufacturer Narrative
Vessel perforation, hematoma or hemorrhage at access site including death are included as possible complications in the instructions for use (ifu) for the indigo aspiration system.The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2022-00540.

• 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: 15820464
• Report Number: 3005168196-2022-00541
• Device Sequence Number: 4754201
• Product Code: QEW
• UDI-Device Identifier: 00815948021556
• UDI-Public: 815948021556
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K202821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2022
• 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: 07/04/2025
• Device Catalogue Number: SEP12
• Device Lot Number: H00000628
• 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: 10/25/2022
• Initial Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2022
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 65 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005