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	Cardiac Perforation (2513)
Date of Event	01/16/2024
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.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the pulmonary artery using an indigo system flash aspiration catheter (flash catheter), a non-penumbra angled pigtail catheter, a neuron select catheter 6f (6f select), a non-penumbra sheath and a non-penumbra guidewire.The physician used the internal jugular vein to gain access to the target location.During the procedure, the physician advanced an angled pigtail catheter and wire into the main pulmonary artery.Then the physician removed the angled pigtail catheter and attempted to advance the flash catheter into the right pulmonary artery; however, the flash catheter would not advance through the heart.The physician then placed a 6f select in the flash catheter over the guidewire.While advancing the flash catheter and the 6f select over the guidewire through the heart, the flash catheter jumped forward.Although no angiography was taken, it was reported that the chordae tendinae of the heart may have been ruptured by the flash catheter.At this point, the patient decompensated and became unresponsive.The code team was called and performed cpr on the patient but were unsuccessful and the patient expired.

• 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: 18677675
• Report Number: 3005168196-2024-00042
• Device Sequence Number: 6195558
• Product Code: QEW
• UDI-Device Identifier: 00815948024861
• UDI-Public: 815948024861
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 02/09/2024
• 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: 08/24/2026
• Device Catalogue Number: LITNGFHT80BER
• Device Lot Number: F00008174
• 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: 01/16/2024
• Initial Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2023
• 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: 70 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005