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

Model Number	LITNG12HTORQ115-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2021
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 femoral and left iliac vein using a lightning aspiration tubing (lightning), an indigo system cat12 aspiration catheter (cat12), and rotating hemostasis valve (rhv).During the procedure, the physician completed approximately three to four passes using the cat12.The physician was then removing the cat12 to be flushed with aspiration on when the indicator light on the lightning turned yellow.Subsequently, after removing the cat12, the physician noticed the threads on the rhv to be broken upon separating the cat12 from the rhv.Therefore, the cat12 and rhv were not used for the remainder of the procedure.The procedure was completed using a new cat12 and rhv with the same 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:3005168196-2021-02764.Evaluation of the returned rotating hemostasis valve (rhv) revealed that the distal portion that inserts into the catheter hub luer was fractured.The root cause of this damage could not be determined.The rhv was attached to a demonstration cat12 and air was observed to be leaking from the connection.Evaluation of the returned cat12 revealed the hub luer was deformed.The root cause of this damage could not be determined.During functional testing, a demonstration rhv was unable to attach to the hub of the cat12 due to the damaged hub luer.Evaluation also revealed the id band had been displaced distally.This is incidental to the reported complaint.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 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: 12945930
• Report Number: 3005168196-2021-02764
• Device Sequence Number: 4803461
• Product Code: QEW
• UDI-Device Identifier: 00815948022577
• UDI-Public: 00815948022577
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 01/16/2022
• 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: 05/11/2024
• Device Model Number: LITNG12HTORQ115-A
• Device Catalogue Number: LITNG12HTORQ115
• Device Lot Number: H11377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• 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: 11/07/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 01/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2021
• 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: 44 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005