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

Catalog Number	LITNG12HTORQ115
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/16/2022
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.Blood loss 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.
Event or Problem Description
On (b)(6) 2022, the patient underwent a thrombectomy procedure in the left common iliac, left common femoral, left femoral, and left popliteal veins using an indigo system lightning aspiration tubing (lightning), an indigo system aspiration catheter 12 (cat12) and an indigo system separator 12 (sep12).During the procedure, the physician performed multiple passes using the cat12 and sep12 from the left common iliac vein to the above-knee popliteal vein.Stenosis of the left common femoral vein were treated with venoplasty and the deployment of 3 stents.Stents were placed from the left common iliac to the common femoral vein.Based on satisfactory results and given patient's discomfort, the procedure was terminated.There were no complications encountered during the procedure.Estimated blood loss was 400 ml.It was reported that the patient had low hemoglobin to begin with.On (b)(6) 2022 post operative day 1, the subject did not have a fever, chills, cough, or nausea.The patient complained of lower extremity fullness and heaviness and had shortness of breath and tachycardia with exertion which were deemed likely related to her pe.A hemoglobin drop from 8.3 g/dl to 6.8 g/dl was noticed and was likely secondary to acute blood loss during the procedure.There were no signs of bleeding at the puncture site.A unit of packed rbc was transfused.Patient's hemoglobin and hematocrit was stable, and patient reported less pain in her left lower extremity.The patient was maintained on therapeutic lovenox and aspirin and was discharged on post operative day 4 with home health services.On (b)(6) 2024, the clinical events committee (cec) adjudicated the acute blood loss to be an adverse event with a possible relationship to the indigo aspiration system and a possible 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: 18773778
• Report Number: 3005168196-2024-00063
• Device Sequence Number: 19949022
• Product Code: QEW
• UDI-Device Identifier: 00815948022577
• UDI-Public: 815948022577
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2024
• 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: 06/13/2025
• Device Catalogue Number: LITNG12HTORQ115
• Device Lot Number: H00000486
• 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: 01/30/2024
• Initial Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• 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: 45 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005