MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12; 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	10/30/2020
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 popliteal artery using a lightning aspiration tubing (lightning) and indigo system aspiration catheter 8 (cat8).During the procedure, the physician completed three passes using the cat8 and lightning.The indicator light on the lightning unit then turned solid red.The physician unplugged and re-plugged the lightning unit several time to troubleshoot; however, the indicator light on the lightning remained solid red.It was reported that the lightning tubing was not flushed.Therefore, it was removed.The procedure was completed using a new lightning.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned lightning confirmed a solid red light.The lightning was plugged in and powered on and a solid red light was illuminated.The lightning housing was opened, and blood was inside the unit, indicating a leak within the unit.This type of damage typically occurs due to over pressurizing the unit when flushing the device.If too strong of a positive pressure is applied, the unit may leak internally.The red-light was likely a result of blood contacting the internal electrical components.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.

• Brand Name: INDIGO SYSTEM LIGHTNING 12
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10897678
• Report Number: 3005168196-2020-02087
• Device Sequence Number: 3228153
• Product Code: QEW
• UDI-Device Identifier: 00815948022546
• UDI-Public: 00815948022546
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K200771
• 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): 10/30/2020
• 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: 11/10/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 73
• Date Report Sent to FDA: 01/01/2005