MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 8; QEW

Model Number	LITNG8XTORQ115-A
Medical Device Problem Codes	Leak/Splash (1354); Obstruction of Flow (2423)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2020
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 left popliteal artery using a lightning aspiration tubing (lightning) and penumbra engine canister (canister).During the procedure, while performing balloon angioplasty, the physician turned off the lightning unit and turned it back on.However, after turning the lightning unit back on, the lightning tubing was obstructed with clot.Subsequently, a guidewire was advanced approximately halfway into the lightning tubing to agitate the clot and the indicator light on the lightning unit turned flashing red.It was reported that it is unknown whether the indicator on the lightning unit was flashing red before or after advancing the guidewire.The hospital staff unplugged the lightning unit and plugged back in but, it was unsuccessful.Upon further inspection of the lightning unit, blood was found to be leaking from the seal between the lightning unit and canister.The procedure was completing using a new lightning and same canister.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2020-01969 1.Section d.Box 1.Brand name.Evaluation of the returned lightning was unable to confirm the reported complaint.The returned lightning was able to aspirate water without issue.Upon opening the housing, blood was found throughout the device.This damage typically occurs if too strong of a positive pressure is introduced to the system.If the lightning is over pressurized when flushed, the unit may leak internally.If blood contacts the internal components of the device, it will likely become non-functional.This is likely what caused the difficulty experienced during the procedure.The unit was likely functional during testing due to the fluid having time to dry during the return to penumbra.Penumbra devices 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.

• Brand Name: INDIGO SYSTEM LIGHTNING 8
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10831487
• Report Number: 3005168196-2020-01969
• Device Sequence Number: 2904095
• Product Code: QEW
• UDI-Device Identifier: 00815948022546
• UDI-Public: 00815948022546
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• 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): 10/17/2020
• 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: 06/22/2023
• Device Model Number: LITNG8XTORQ115-A
• Device Catalogue Number: LITNG8XTORQ115
• Device Lot Number: H10567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/17/2020
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Date Report Sent to FDA: 01/01/2005