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

Model Number	LITNG12HTORQ115-A
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
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 using lightning aspiration tubing (lightning) in the pulmonary artery.During the procedure, the indicator light on a lightning was solid red at the start of the case.The lightning was then removed, and the hospital staff used a new lightning to complete the procedure.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 device was plugged into a demonstration engine with the switch in the off position.The green indicator light illuminated, and then the light turned into solid red.The error code was checked and indicated that the switch pressure sensor was not functioning properly.The lightning housing was opened, and no damage was observed.The lightning power cable was disconnected and reconnected and the same issue occurred.The root cause of this issue could not be determined.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of solid red light indicator.

• 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: 12222087
• Report Number: 3005168196-2021-01656
• Device Sequence Number: 14443618
• Product Code: QEW
• UDI-Device Identifier: 00815948022577
• UDI-Public: 00815948022577
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K210323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2021
• 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: 02/16/2024
• Device Model Number: LITNG12HTORQ115-A
• Device Catalogue Number: LITNG12HTORQ115
• Device Lot Number: F103892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• 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: 06/30/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2021
• 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
• Patient Age: 49 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005