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

Model Number	LITNG12XTORQ100-A
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned lightning could not confirm the reported complaint.The lighting unit was tested on a demonstration engine and canister and functioned as intended.The lightning illuminated green when plugged into the engine and was able to aspirate fluid without an issue.The root cause of the reported complaint could not be determined.Penumbra 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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the portal vein using lightning aspiration tubing (lightning), an indigo system aspiration catheter 12 (cat12), a penumbra engine canister (canister), a non-penumbra sheath, and a guidewire.During the procedure, the physician flushed the cat12 with saline and attached a rotating hemostasis valve (rhv) to the cat12.Then the cat12 was advanced into the sheath and the lightning was placed onto the canister.Subsequently, the lightning was plugged into the engine and the indicator light on the lightning unit illuminated green.Next, upon connecting the lightning tubing to the rhv, the lightning unit turned solid red.To troubleshoot, the lightning was unplugged from the engine for 30 seconds and replugged, and the engine was unplugged from the power outlet for 30 seconds and replugged; however, the same issue occurred.Therefore, the lightning was removed.The procedure was completed using a new lightning and the same cat12 and canister.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 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: 12888873
• Report Number: 3005168196-2021-02699
• Device Sequence Number: 13833178
• Product Code: QEW
• UDI-Device Identifier: 00815948022560
• UDI-Public: 00815948022560
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K202821
• 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
• Report Date (Section B): 11/29/2021
• 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: 02/19/2024
• Device Model Number: LITNG12XTORQ100-A
• Device Catalogue Number: LITNG12XTORQ100
• Device Lot Number: F104001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• 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: 11/03/2021
• Initial Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2021
• 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: 32 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005