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

Model Number	LITNG8XTORQ115-A
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2020
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the iliofemoral vein using an indigo system lightning aspiration tubing (tubing).During the procedure, the tubing appeared to be clogged with the clot; therefore, the physician disconnected the tubing from the catheter.Then, attempted to connect a 30cc syringe to the tubing and flush it to the canister.However, the unit turned red when the physician flushed with the saline.The tubing was then disconnected and reconnected; however, the unit stayed red.Therefore, the tubing was disconnected and not used for the remainder of the procedure.The procedure was completed using a new tubing.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the iliofemoral vein using an indigo system lightning aspiration tubing (lightning).During the procedure, the lightning tubing appeared to be clogged with the clot; therefore, the physician disconnected the lightning tubing from the catheter.Then, attempted to connect a 30cc syringe to the lightning tubing and flush it to the canister.However, the unit turned red when the physician flushed with the saline.The lightning unit was power cycled; however, the unit stayed red.Therefore, the lightning was removed and not used for the remainder of the procedure.The procedure was completed using a new lightning.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: (b)(4).1.Section b.Box 5.Describe event or problem h3 other text : placeholder.
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 #02 mfr report:3005168196-2020-00981.

• Brand Name: INDIGO SYSTEM LIGHTNING 12
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10292837
• Report Number: 3005168196-2020-00981
• Device Sequence Number: 16377742
• Product Code: QEW
• UDI-Device Identifier: 00815948022546
• UDI-Public: 00815948022546
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K193244
• 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,Followup
• Report Date (Section B): 06/20/2020
• 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: 04/03/2023
• Device Model Number: LITNG8XTORQ115-A
• Device Catalogue Number: LITNG8XTORQ115
• Device Lot Number: H10403
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/20/2020
• Supplement Date Received by Manufacturer: 01/14/2005; 01/14/2005
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 08/12/2020; 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Date Report Sent to FDA: 01/01/2005