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

Catalog Number	LITNGFHT115BER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	09/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Vessel perforation is included as possible complication in the instructions for use (ifu) for the indigo aspiration system.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.H3 other text : placeholder.
Event or Problem Description
On (b)(6) 2023, the patient underwent a thrombectomy procedure in the right interlobar segment, right middle lobe, and right lower lobe using an indigo system flash aspiration catheter (flash catheter) and a non-penumbra sheath.It was reported that during the procedure, there was difficulty advancing the flash catheter and sheath due to the tortuosity of the pulmonary artery with an acute angle coming from the right ventricular outflow tract (rvot).After completion of the procedure, while removing the aspiration catheter, the patient started to experience nausea and lost consciousness and began experiencing pulmonary embolism (pe) cardiac arrest.The physician performed cardiopulmonary resuscitation (cpr) and cardiac anesthesia.It was reported that a computed tomography (ct) surgery and extracorporeal membrane oxygenation (ecmo) team were called in.The physician then decided to perform an open surgery repair for concerns of a right ventricular (rv) perforation and cardiac tamponade.The ct surgery team performed an urgent sternotomy and noted an injury to the right ventricular outflow tract (rvot).It was also reported that an injury was seen in the right ventricle (rv) which was caused by one of the drains during placement.The site of the injuries was repaired primarily with pledgeted suture.The access site of the femoral artery was repaired with good distal pulses.Hemodynamics were adequate and the patient remained on some inotropic support.The sternum was closed with parasternal wires and then layer by layer approach to skin and subcutaneous tissues.The patient was transferred to the intensive care unit (icu) and then discharged to an extended care facility.The rv injury was reported to be a serious adverse event with a probable relationship to the flash catheter and a definite relationship to the index procedure.
Additional Manufacturer Narrative
Please note that the following sections were updated based on additional information received from penumbra clinical team on (b)(6) 2024: 1.Section d.Box 4.Lot #, 2.Section d.Box 4.Catalog#, 3.Section d.Box 4.Expiration date, 4.Section d.Box 4.Unique identifier, 4.Section h.Box 4.Device manufacture date.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: 18548427
• Report Number: 3005168196-2024-00031
• Device Sequence Number: 7780372
• Product Code: QEW
• UDI-Device Identifier: 00815948024892
• UDI-Public: 815948024892
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K222358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2024
• 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: 02/15/2026
• Device Catalogue Number: LITNGFHT115BER
• Device Lot Number: F00005554
• 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: 09/29/2023
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2023
• 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: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005