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 Codes	Hemoptysis (1887); Perforation (2001)
Date of Event	03/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Perforation is included as possible complication in the instructions for use (ifu) for the indigo system flash aspiration catheter.The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right pulmonary artery (rpa) and the left pulmonary artery (lpa) using an indigo system flash aspiration catheter (flash catheter), an indigo system lightning flash aspiration tubing (flash tubing), and a non-penumbra sheath.During the procedure, it was reported that the flash catheter was tight in the sheath.The physician successfully removed thrombus from both the target locations.While removing the flash catheter, the physician lubricated the proximal end of the flash catheter and the sheath.Subsequently, the physician attempted to rotate the flash catheter in the sheath to help remove the flash catheter; however, while doing this, the physician lost control of the sheath and the sheath advanced 2-3 cm forward causing a small perforation in the right upper lobe.The procedure ended at this point.The patient had a brief period of hemoptysis which resolved on its own.It was reported that the patient''s vitals and oxygen saturation improved drastically after the procedure.

• 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: 16744742
• Report Number: 3005168196-2023-00170
• Device Sequence Number: 6445746
• Product Code: QEW
• UDI-Device Identifier: 00815948024892
• UDI-Public: 815948024892
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/14/2023
• 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: 01/03/2026
• Device Catalogue Number: LITNGFHT115BER
• Device Lot Number: F00004832
• 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: 03/24/2023
• Initial Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• 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: Other
• Patient Age: 72 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005