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

Catalog Number	LITNGFHT100BER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Great Vessel Perforation (2152)
Date of Event	02/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right and left pulmonary arteries using an indigo system flash aspiration catheter (flash catheter), an indigo system lightning flash aspiration tubing (flash tubing), a non-penumbra balloon tipped diagnostic catheter (100cm), a non-penumbra sheath, an exchange length wire, and a guidewire.During the procedure, several passes were completed in the left and right pulmonary arteries using the flash catheter.After completion of the procedure, the patient started to code.An angiogram was performed using a balloon tipped diagnostic catheter and revealed vessel perforation in the proximal portion of the main pulmonary artery.The physician then placed a transverse abdominis plane (tap) drainage catheter in the patient to release blood from the pericardium.It was reported that the patient is now fully functioning and has made major progress.
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 is included as a possible complication 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.

• 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: 18773344
• Report Number: 3005168196-2024-00059
• Device Sequence Number: 7702064
• Product Code: QEW
• UDI-Device Identifier: 00815948024885
• UDI-Public: 815948024885
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/23/2024
• 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: 09/12/2026
• Device Catalogue Number: LITNGFHT100BER
• Device Lot Number: F00008441
• 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: 02/02/2024
• Initial Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2023
• 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 Sex: Female
• Date Report Sent to FDA: 01/01/2005