MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 8; QEW

Model Number	LITNG8XTORQ115-A
Medical Device Problem Code	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	09/09/2020
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 pulmonary artery using a lightning aspiration tubing (lightning), indigo system aspiration catheter 8 (cat8), and penumbra engine (engine).During the procedure, the physician accessed the internal jugular vein and proceeded to clear the pulmonary embolism (pe) using the cat8.The cat8 was working well initially.However, while the physician was aspirating clot, the vacuum pressure suddenly stopped, and the indicator light on the lightning turned from green to solid red.Subsequently, the physician made attempts to troubleshoot the clogged lightning.The engine was unplugged and powered off.Next, an attempt was made to clear the lightning by dipping the lightning into saline with aspiration on, putting a finger over the end of the lighting and tapping the lightning while submerged in saline.Additionally, a dilator was used to gently flush the end of the lightning with aspiration on.However, the issue with the lightning was unable to be resolved.Therefore, the lightning was not used for the remainder of the procedure.The procedure was completed using another lightning and the same cat8.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report 3005168196-2020-01656.Section d.Box 1.Brand name.Results: there was no damage to the exterior of the lightning.Conclusions: evaluation of the returned lighting was unable to confirm the reported event.The lightning was plugged in and powered on without issue.During functional testing, all visual and audio cues operated as intended.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.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report: 3005168196-2020-01656.Section g.Box 5.510(k)#.

• Brand Name: INDIGO SYSTEM LIGHTNING 8
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10640907
• Report Number: 3005168196-2020-01656
• Device Sequence Number: 2439410
• Product Code: QEW
• UDI-Device Identifier: 00815948022546
• UDI-Public: 00815948022546
• Combination Product (Y/N): Y
• Initial Reporter State: WY
• 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,Followup
• Report Date (Section B): 09/11/2020
• 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: LITNG8XTORQ115-A
• Device Catalogue Number: LITNG8XTORQ115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 11/20/2020; 01/14/2005
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 12/17/2020; 12/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005