MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12; QEW

Catalog Number	LITNG12XTORQ100
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	09/14/2022
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 lightning 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
On (b)(6) 2022, the patient underwent a thrombectomy procedure to remove clot located at the baseline (bl) and treatment (tx) using an indigo system aspiration catheter 12 (cat12) and lightning aspiration tubing (lightning).It was reported that hypotension was encountered during the procedure.The patient required fluid bolus, neo-synephrine, and levophed infusion with returning of baseline blood pressure to 106/49 mmhg and heart rate of 72 bpm.The clinical deterioration was reported to be adverse event with a possible relationship to the indigo aspiration system and index procedure.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by independent medical reviewer (imr) on 03/13/2023: 1.Section b.Box 5.Describe event or problem.Note: the hypotension was previously adjudicated to be a serious adverse event with a possible relationship to the indigo aspiration system and index procedure.However, on (b)(6) 2023, additional information received adjudicated that the hypotension was unrelated to the indigo aspiration system with a definite relationship to the index procedure.Therefore, this event is not considered reportable against the indigo aspiration system.H3 other text : placeholder.
Event or Problem Description
On (b)(6) 2022, the patient underwent a thrombectomy procedure to remove clot located at the baseline (bl) and treatment (tx) using an indigo system aspiration catheter 12 (cat12) and lightning aspiration tubing (lightning).It was reported that hypotension was encountered during the procedure.The patient required fluid bolus, neo-synephrine, and levophed infusion with returning of baseline blood pressure to 106/49 mmhg and heart rate of 72 bpm.The clinical deterioration was reported to be adverse event with a possible relationship to the indigo aspiration system and index procedure.On 13-mar-2023, additional information received indicated that the independent medical reviewer (imr) adjudicated the hypotension to be unrelated to the indigo aspiration system with a definite relationship to the index procedure.

• Brand Name: INDIGO SYSTEM LIGHTNING 12
• 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: 15649741
• Report Number: 3005168196-2022-00491
• Device Sequence Number: 17633877
• Product Code: QEW
• UDI-Device Identifier: 00815948022560
• UDI-Public: 815948022560
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K210323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2023
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/30/2025
• Device Catalogue Number: LITNG12XTORQ100
• Device Lot Number: H12907
• 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: 09/28/2022
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• 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: 86 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005