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	Low Blood Pressure/ Hypotension (1914)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Hypotension is included as a 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 manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient underwent a thrombectomy procedure in the posterior segmental, right lower lobe, anterior basal segmental, lateral basal segmental, medial basal segmental, posterior basal segmental, apical segmental, lingular, and left lower lobe using an indigo system lightning flash aspiration catheter (flash catheter).Following the completion of thrombectomy, the patient reported dizziness and hypotension was reported.The physician provided the patient fluid resuscitation with 500 ml of normal saline in a pressure bag.The episode of hypotension was considered vasovagal, not secondary to blood loss.It was reported that blood transfusion was performed.Hypotension was considered possibly related to the indigo aspiration system and possibly related to the index procedure.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by penumbra clinical team on (b)(6) 2024: 1.Section b.Describe event or problem.Note: the hypotension was considered vasovagal syndrome and was previously adjudicated to be possibly related to the flash catheter.However, on (b)(6) 2024, an update was received indicating that the vasovagal syndrome is unrelated to the flash catheter.Therefore, this event is not considered reportable against the flash catheter.H3 other text : placeholder.
Event or Problem Description
The patient underwent a thrombectomy procedure in the posterior segmental, right lower lobe, anterior basal segmental, lateral basal segmental, medial basal segmental, posterior basal segmental, apical segmental, lingular, and left lower lobe using an indigo system lightning flash aspiration catheter (flash catheter).Following the completion of thrombectomy, the patient reported dizziness and hypotension was reported.The physician provided the patient fluid resuscitation with 500 ml of normal saline in a pressure bag.The episode of hypotension was considered vasovagal, not secondary to blood loss.It was reported that blood transfusion was performed.Hypotension was considered possibly related to the indigo aspiration system and possibly related to the index procedure.On (b)(6) 2024, an update was received from the site indicating that the possible relationship of vasovagal syndrome is unrelated to the indigo aspiration system.

• 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: 18036069
• Report Number: 3005168196-2023-00485
• Device Sequence Number: 20687803
• Product Code: QEW
• UDI-Device Identifier: 00814548012384
• UDI-Public: 814548012384
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 02/25/2024
• 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: LITNGFHT100BER
• Device Lot Number: F00007251
• 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: 10/05/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 02/25/2024
• 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: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005