MAUDE Adverse Event Report: PENUMBRA, INC. LIGHTNING ASPIRATION TUBING; QEW

Model Number	LITNG12HTORQ100-A
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2021
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 right atrium using a lightning aspiration tubing (lightning) and an indigo system cat12 aspiration catheter (cat12).During the procedure, upon plugging in the lightning unit, the indicator light on the lightning unit initially turned green and then immediately turned solid red.It was also reported that the physician unplugged and plugged the lightning unit back into the usb port to troubleshoot; however, the lightning unit remained solid red.Therefore, the lightning unit was removed.The procedure was completed using a new lightning unit and the same cat12.There was no adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned lightning confirmed a solid red light.Evaluation revealed the pressure sensor in the switch was not fully connected to the housing.The lightning was unable to aspirate water into the canister.After properly re-seating the pressure sensor connector, and the unit functioned as intended.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.H3 other text : placeholder.

• Brand Name: LIGHTNING ASPIRATION TUBING
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12380398
• Report Number: 3005168196-2021-01926
• Device Sequence Number: 14446416
• Product Code: QEW
• UDI-Device Identifier: 00815948022553
• UDI-Public: 00815948022553
• 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): 08/27/2021
• 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: F101966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/07/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 10/05/2021
• 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: 63
• Date Report Sent to FDA: 01/01/2005