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

Model Number	LITNG8XTORQ115-A
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); 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	09/17/2020
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), an indigo system aspiration catheter 12 (cat12), and a penumbra engine (engine).During the procedure, prior to use with the patient, the indicator light of the lightning immediately turned solid red when the lightning was connected to the engine on the back table.The lightning was rebooted three times; however, the indicator light remained red.The issue with the lightning occurred prior to use and, therefore, the lightning was not used in the procedure.Next, the physician used the lightning from an indigo system lightning 8 with the same cat12.When the lightning was connected to the engine, the indicator light also turned red.The lightning was successfully rebooted and was used with the patient.Approximately ten minutes into the aspiration, the lightning and cat12 became full of clot and the indicator light of the lightning turned red again.Therefore, the lightning was disconnected, flushed with a 10 cc syringe and rebooted.The procedure was successfully completed using the same lightning, cat12, and engine.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2020-01711.1.Section a.Box 2.Date of birth 2.Section a.Box 2.Age at time of event results: there was no damage to the exterior of the lightning unit.Conclusions: evaluation of returned lightning revealed a functioning device.There was no damage to the exterior of the device.During functional testing, all audio and visual cues operated as intended.The root cause of the reported event could not be determined.Penumbra lightning aspiration tubing is 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.H3 other text : placeholder.

• Brand Name: INDIGO SYSTEM LIGHTNING 8
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10659932
• Report Number: 3005168196-2020-01711
• Device Sequence Number: 11650660
• Product Code: QEW
• UDI-Device Identifier: 00815948022546
• UDI-Public: 00815948022546
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 09/17/2020
• 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: H10567
• 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: 09/17/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 10/10/2020
• Supplement Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 95
• Date Report Sent to FDA: 01/01/2005