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

Catalog Number	LITNGFXT100H1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	02/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the popliteal vein using an indigo system flash aspiration catheter (flash catheter), an indigo system lightning flash aspiration tubing (flash tubing), an indigo system aspiration catheter 12 (cat12), a penumbra engine (engine) and a non-penumbra sheath.It was reported that the patient had a distinct anatomy with a duplicated popliteal vein.During the procedure, the physician attempted to access one of the duplicated popliteal veins with the cat12; however, the access was not successful.Therefore, the physician decided to re-access the larger popliteal vein with the flash catheter.After access was gained with the flash catheter, it was noticed that the flash tubing was illuminating flashing red light.Therefore, the flash catheter and the flash tubing were removed.The physician completed one pass using a new flash catheter over the guidewire.The guidewire was then removed, and the physician decided to do one more pass without the guidewire.When the flash catheter was advanced for a second pass, a perforation was noted from the femoral vein at the mid thigh level.A final venogram revealed the perforation had resolved on its own.Since there was a significant clinical improvement, no additional intervention or imaging were necessary, and the patient was discharged home.The perforated femoral vein was reported to be an adverse event with a definite relationship to the indigo aspiration system and the index procedure.On 15-mar-2024, information received indicated that the perforated femoral vein was a serious adverse event.
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.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: 19055737
• Report Number: 3005168196-2024-00130
• Device Sequence Number: 7069603
• Product Code: QEW
• UDI-Device Identifier: 00815948024823
• UDI-Public: 815948024823
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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
• Report Date (Section B): 04/05/2024
• 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: 06/19/2026
• Device Catalogue Number: LITNGFXT100H1
• Device Lot Number: F00007256
• 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: 02/06/2024
• Initial Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2023
• 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: 78 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005