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

Model Number	LITNG12XTORQ115-A
Medical Device Problem Codes	Circuit Failure (1089); Obstruction of Flow (2423)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2020
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the femoral and iliac vein using a lightning aspiration tubing (lightning), an indigo system aspiration catheter 12 (cat12) and a penumbra engine (engine).During the procedure, there was an initial strong aspiration when the physician turned the engine on.Subsequently, the lightning clogged and the indicator light on the lightning unit turned from green to red.Therefore, the physician attempted to use a syringe to flush the thrombus through the lightning.The physician was able to flush the majority of the thrombus out of the lightning; however, the indicator light remained red.Next, the physician unplugged and re-plugged the lightning unit from the engine a few times but the indicator light remained red.Lastly, the physician power cycled the engine and the indicator light remained red; therefore, the lightning was removed and not used for the remainder of the procedure.The procedure was completed using a new lightning and the same cat12.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: blood was visible within the lightning housing.Conclusions: evaluation of the returned lightning revealed a leak within the units housing.During functional testing, the unit was unable to power on; therefore, the reported issue could not be confirmed.If a strong positive pressure is applied to the lightning tubing, a leak may occur within the housing.If a leak does occur, the unit will likely display a solid red-light system error and become non-functional.Penumbra lightning aspiration tubing is inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

• Brand Name: INDIGO SYSTEM LIGHTNING 12
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10794415
• Report Number: 3005168196-2020-01894
• Device Sequence Number: 3680746
• Product Code: QEW
• UDI-Device Identifier: 00815948022591
• UDI-Public: 00815948022591
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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): 10/06/2020
• 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 Model Number: LITNG12XTORQ115-A
• Device Catalogue Number: LITNG12XTORQ115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Date Report Sent to FDA: 01/01/2005