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

Model Number	LITNG12HTORQ100-A
Medical Device Problem Codes	Connection Problem (2900); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2020-02323.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat a iliofemoral deep vein thrombosis (dvt) using a lightning aspiration tubing (tubing), an indigo system aspiration catheter 12 (cat12), an indigo system separator 12 (sep12) and a penumbra engine (engine).During the procedure, while aspirating using a cat12 without the use of a sep12, the physician noticed that the indicator light on the lighting turned red.Then, the physician turned the flow switch off and the lightning unit was unplugged from the back of the engine.After thirty seconds, the lightning unit was plugged back in and it was noticed that the indicator light on the lightning was green.However, after a few seconds later, the indicator light on the lightning turned back red.Therefore, the lightning unit was removed and replaced.Afterwards, the physician decided to continue the case using an indigo system separator 12 (sep12).Therefore, the rotating hemostasis valve (rhv) was connected to the cat12 outside the patient and while loosening the valve to allow the sep12 to be inserted into the cat12, the valve came off and would not go back on.Multiple attempts were made to have the valve back on the rhv; however, were unsuccessful.The procedure was completed using a new lightning unit, a new rhv, the same cat12, the same sep12, and the same engine.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM LIGHTNING 12
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11051812
• Report Number: 3005168196-2020-02324
• Device Sequence Number: 14093373
• Product Code: QEW
• UDI-Device Identifier: 00815948022553
• UDI-Public: 00815948022553
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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
• Report Date (Section B): 11/27/2020
• 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: 06/16/2023
• Device Model Number: LITNG12HTORQ100-A
• Device Catalogue Number: LITNG12HTORQ100
• Device Lot Number: F98380
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2020
• Initial Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Date Report Sent to FDA: 01/01/2005