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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-00525.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the iliac artery using a lightning aspiration tubing (lightning), an indigo system aspiration catheter 8 (cat8), an aspiration tubing (tubing), a penumbra engine (engine), and a penumbra engine canister (canister).During the procedure, the indicator light on the lightning unit turned solid red after turning the flow switch to the on position.To troubleshoot, the physician unplugged and plugged back in the cord from the lightning to the usb port on the engine, flushed the cat8 and tubing, as well as making sure that the canister was seated properly on the engine.However, the lightning unit remained solid red and none of the four indicator lights on the engine illuminated.Subsequently, the lightning was removed and exchanged for a new lightning, but the same issue occurred.The physician then exchanged the engine for a second engine, but the lightning unit remained solid red and none of the four indicator lights on the engine illuminated.Therefore, the physician removed the canister.It was also reported that the first engine was tested with the new canister and it was noted that the engine was able to achieve full aspiration without any issue.The procedure was completed using the same second lightning, the same second engine, and a new canister.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned lightning was unable to confirm the reported solid red-light.The lightning functioned as intended when connected to the returned canister on a demonstration engine.If the lightning is switched on without vacuum present in the canister it will blink red.Evaluation of the returned canister revealed that the lid was not properly seated on the canister housing.If the lid is not properly seated on the canister it will seal; therefore, no vacuum pressure will build up in the canister.This likely caused the difficulty experienced during the procedure and would cause the lightning to flash red when switched on.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.This report is associated with mfr report number: 3005168196-2021-00525.

• Brand Name: INDIGO SYSTEM LIGHTNING 8
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11510454
• Report Number: 3005168196-2021-00524
• Device Sequence Number: 3843970
• Product Code: QEW
• UDI-Device Identifier: 00815948022546
• UDI-Public: 00815948022546
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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): 02/16/2021
• 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: 08/11/2023
• Device Model Number: LITNG8XTORQ115-A
• Device Catalogue Number: LITNG8XTORQ115
• Device Lot Number: H10690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Date Report Sent to FDA: 01/01/2005