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 Code	Pulmonary Embolism (1498)
Date of Event	03/24/2024
Type of Reportable Event	Serious Injury
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.The product lot number was not provided; therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2024-00327.
Event or Problem Description
On (b)(6) 2024, the patient underwent a thrombectomy procedure in the apical segmental, right lower lobe, and left pulmonary artery using an indigo system aspiration catheter 12 (cat12), an indigo system separator 12 (b)(6), and a penumbra engine (engine).There were no reported procedural complications.On (b)(6) 2024, the patient¿s general condition suddenly deteriorated, with the occurrence of a pulseless electrical activity (pea) cardiac arrest.Cardiopulmonary resuscitation (cpr) was initiated, and after administration of adrenaline, the patient was successfully resuscitated.The patient was then intubated and transported for a follow up computed tomography (ct) scan of the head and pulmonary arteries.The ct of the head revealed no obvious sign of fresh bleeding, but the ct angiography of the chest showed a recurrence pulmonary embolism (pe) in the left and right pulmonary arteries.Features of right ventricular overload were noted, inducing pulmonary edema.The patient was then transferred to another hospital for cardiac surgery and placed on extracorporeal membrane oxygenation (ecmo).After successful treatment, the patient was returned to the original hospital.The event is considered resolved.The independent medical reviewer (imr) adjudicated the pulmonary embolism recurrence as a serious adverse event with a possible relationship to the indigo system aspiration catheter 12 and the indigo system separator 12, and a possible relationship to the index procedure.

• 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: 20308561
• Report Number: 3005168196-2024-00328
• Device Sequence Number: 15674358
• Product Code: QEW
• UDI-Device Identifier: 00815948021549
• UDI-Public: 00815948021549
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K202821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/26/2024
• 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 Catalogue Number: SEP12
• 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: 09/02/2024
• Initial Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005