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

Model Number	LITNG12HTORQ100-A
Medical Device Problem Codes	Obstruction of Flow (2423); Free or Unrestricted Flow (2945)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2020
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 in the iliac vein using a lighting aspiration tubing (lightning) and indigo system aspiration catheter 12 (cat12).During the procedure, the cat12 was advanced into the clot and became occlusive in clot.It was reported there was slow movement of the clot advancing up through the lightning.Once the clot hit the flow switch, the lightning unit turned solid red.To troubleshoot, the lightning was unplugged from the engine and reset.The red indicator light remained solid red, resulting in no additional vacuum pressure.At this point, blood began leaking out of the flow switch and onto the table.Therefore, the lightning was removed.The procedure was completed by hooking up a syringe to the same cat12.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned lightning could not confirm the solid red light.The lightning was connected to a demonstration canister and engine.The lightning was switched on and fluid was aspirated into the canister without an issue.No leaks were observed during the functional test.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.

• Brand Name: INDIGO SYSTEM LIGHTNING 12
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11143704
• Report Number: 3005168196-2021-00051
• Device Sequence Number: 19038664
• Product Code: QEW
• UDI-Device Identifier: 00815948022553
• UDI-Public: 00815948022553
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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): 12/11/2020
• 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 Expiration Date: 08/17/2023
• Device Model Number: LITNG12HTORQ100-A
• Device Catalogue Number: LITNG12HTORQ100
• Device Lot Number: F99569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 01/09/2021
• Supplement Report FDA Received Date: 05/18/2021
• 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