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

Catalog Number	LITNGFHT80BER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Anemia (1706)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
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.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.
Event or Problem Description
On (b)(6) 2024, the patient underwent a thrombectomy procedure using an indigo system lightning flash aspiration tubing (flash tubing), indigo system flash aspiration catheter (flash catheter), and a neuron select catheter 6f (6f select).The patient''s baseline hemoglobin was noted to be 11 g/dl before the procedure and dropped to 5.1 g/dl post procedure.The patient received a transfusion of 2 units of packed red blood cells to treat the anemia.It was reported that a ct scan of the pelvis showed no signs of a gi bleed.Anemia was reported to be a serious adverse event with a possible relationship to the indigo aspiration system and a possible relationship to the index procedure.

• Brand Name: INDIGO SYSTEM LIGHTNING FLASH
• 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: 19201572
• Report Number: 3005168196-2024-00162
• Device Sequence Number: 7927364
• Product Code: QEW
• UDI-Device Identifier: 00815948024861
• UDI-Public: 815948024861
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 04/29/2024
• 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: LITNGFHT80BER
• Device Lot Number: F00008439
• 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: 04/02/2024
• Initial Report FDA Received Date: 04/29/2024
• 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 Age: 61 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005