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

Model Number	LITNG12HTORQ100-A
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left and right pulmonary arteries using lightning aspiration tubing (lightning), an indigo system aspiration catheter 12 (cat12), and a penumbra engine (engine).During the procedure, after connecting the lightning to the engine, the lightning unit light would not turn on.The engine was power-cycled and the lightning usb cable was re-connected without success.It was also reported that the physician attempted to use another engine without success.Therefore, the physician decided to exchange the lightning for a new one, and successful thrombectomy was performed using the new lightning and the same cat12.Next, while catheterizing the left pulmonary artery, the lightning unit became clogged.The tubing was flushed with saline and subsequently, the lightning unit indicator light turned red and did not resolve.Therefore, the lightning was removed.The procedure was completed using a new lightning and the same cat12.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: 12362750
• Report Number: 3005168196-2021-01881
• Device Sequence Number: 14408515
• Product Code: QEW
• UDI-Device Identifier: 00815948022553
• UDI-Public: 00815948022553
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• 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): 08/24/2021
• 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: 11/13/2023
• Device Model Number: LITNG12HTORQ100-A
• Device Catalogue Number: LITNG12HTORQ100
• Device Lot Number: F101965
• 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: 07/28/2021
• Initial Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 105
• Date Report Sent to FDA: 01/01/2005