MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 8; QEW

Model Number	LITNG8XTORQ115-A
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left superficial femoral artery (sfa) and popliteal artery using a lightning aspiration tubing (lightning) and indigo system aspiration catheter 8 (cat8).During the procedure, the physician made several passes in the target location using the cat8.Subsequently, after the third pass, the physician disconnected the lightning from the rotating hemostasis valve (rhv) to clean the lightning, and the indicator light on the lightning turned from green to solid red.At this point, there was not a lot of clot burden in the lightning.The physician attempted to troubleshoot the lightning by flushing the lightning with a 60cc syringe and stopcock, followed by unplugging the lightning from the engine and plugging the lightning back into the engine.However, the indicator light remained solid red.Therefore, the lightning was removed.The procedure was completed using a new lightning and the same cat8.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report:3005168196-2020-02258.Evaluation of the returned lightning confirmed a solid red light due to a leak.During the functional test, the lighting unit was powered on and a solid red light occurred, which revealed that the solenoid failed to open.The lightning housing was opened, and a leak was observed coming from the proximal pinch tubing and blood was inside the solenoid.This typically occurs due to over pressurizing the device when attempting to flush the tubing.If too strong of a positive pressure is applied, the tubing may leak within the unit.This leak likely contributed to the solenoid getting stuck and resulted in a solid red light.Penumbra devices are visually inspected during in-process inspection and during quality inspection after manufacturing.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 LIGHTNING 8
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10998236
• Report Number: 3005168196-2020-02258
• Device Sequence Number: 17034667
• Product Code: QEW
• UDI-Device Identifier: 00815948022546
• UDI-Public: 00815948022546
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K193244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/22/2023
• Device Model Number: LITNG8XTORQ115-A
• Device Catalogue Number: LITNG8XTORQ115
• Device Lot Number: H10568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 12/13/2020
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Date Report Sent to FDA: 01/01/2005