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

Model Number	LITNG12HTORQ100-A
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
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: 3005168196-2021-01671.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left popliteal and superficial femoral vein (sfv) to the common femoral using a lightning aspiration tubing (lightning), indigo system cat12 aspiration catheter (cat12), and penumbra engine (engine).During the procedure, the indicator light on the lightning unit immediately turned solid red after plugging into the engine.The physician unplugged and plugged the lightning unit multiple times to troubleshoot; however, it was unsuccessful.It was reported that the engine was removed and replaced with another engine, but the indicator light on the lightning unit remained solid red when plugged into the second engine.Therefore, the lightning unit was removed.Subsequently, the physician opened a new lightning kit and plugged in the lightning unit into the engine; however, the indicator light for the lightning unit turned solid red as well.The lightning unit was therefore, removed.The procedure was completed using the aspiration tubing (tubing) from an indigo system catd aspiration catheter (catd) with the same cat12 from the first lightning kit and the first engine.There was no adverse effect to the patient.It was also reported after the procedure was completed, a penumbra sales representative tested the second engine with a demo lightning and was able to achieve aspiration.
Additional Manufacturer Narrative
Evaluation of the first returned lightning confirmed a solid red light.Evaluation revealed the pressure sensor in the switch was not fully connected to the housing.The lightning was unable to aspirate water into the canister.After properly re-seating the pressure sensor connector, and the unit functioned as intended.Evaluation of the second returned lightning confirmed a solid red light.Evaluation revealed the pressure sensor in the switch was not fully connected to the housing.The lightning was unable to aspirate water into the canister.After properly re-seating the pressure sensor connector, and the unit functioned as intended.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: 3005168196-2021-01671.

• Brand Name: INDIGO SYSTEM LIGHTNING 12
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12232356
• Report Number: 3005168196-2021-01672
• Device Sequence Number: 3611806
• Product Code: QEW
• UDI-Device Identifier: 00815948022553
• UDI-Public: 00815948022553
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K210323
• 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): 08/12/2021
• 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: 11/13/2023
• Device Model Number: LITNG12HTORQ100-A
• Device Catalogue Number: LITNG12HTORQ100
• Device Lot Number: F101964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005