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

Model Number	LITNG12HTORQ115-A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
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 vein using a lightning aspiration tubing (lightning), an indigo system aspiration catheter 12 (cat12), and a 12f non-penumbra sheath.During the procedure, while aspirating clot for approximately five to ten minutes using the lightning and cat12, the lightning unit turned solid red.It was reported by the physician that fluids were leaking from the bottom of the lightning unit where it attaches to the canister.Therefore, the lightning and cat12 were removed.It should be noted that there was no reported issue with the cat12.The procedure was completed using a new lightning and cat12.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned lightning revealed blood inside the unit, confirming the leaking fluid.The lighting unit was connected to a demonstration engine and canister, but the lighting did not power on and no lights illuminated; therefore, the reported solid red light could not be confirmed.The lighting unit was opened, and blood was present within the unit, and the tubing was disconnected without force.The loose tubing likely contributed to the leak inside the unit, and the lighting unit¿s inability to power on during the functional test.If a strong positive pressure is applied to the aspiration tubing, damage such as this may occur.Penumbra aspiration tubing are 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.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being included on this follow-up #03 mfr report: 1.Section g.Box 3.Report source please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #03 mfr report: 1.Section d.Box 1.Brand name h3 other text : placeholder.

• Brand Name: INDIGO SYSTEM LIGHTNING 12
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12755695
• Report Number: 3005168196-2021-02495
• Device Sequence Number: 4151514
• Product Code: QEW
• UDI-Device Identifier: 00815948022577
• UDI-Public: 00815948022577
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K210323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2022
• 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: LITNG12HTORQ115-A
• Device Catalogue Number: LITNG12HTORQ115
• Device Lot Number: F99572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• 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: 10/08/2021
• Supplement Date Received by Manufacturer: 11/08/2021; 01/14/2005
• Initial Report FDA Received Date: 11/06/2021
• Supplement Report FDA Received Date: 11/19/2021; 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005