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

Model Number	LITNG12XTORQ100-A
Medical Device Problem Codes	Leak/Splash (1354); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2021
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 pulmonary artery using an indigo system aspiration catheter 12 (cat12), an indigo system separator 12 (b)(6), a non-penumbra sheath, and a guidewire.During the procedure, the physician used the cat12 and the rotating hemostasis valve (rhv) for approximately twenty minutes and completed a few passes.The physician then attempted to advance the (b)(6) through the rhv; however, it would not advance.It was then noticed that the rhv was leaking air and the rhv could not be resealed; therefore, the rhv was removed.The procedure was completed using a new rhv, the same cat12, and the same (b)(6).There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned rhv revealed that the seal within the rhv was damaged.This damage likely contributed to the inability to advance a sep12 through the rhv during the procedure.During functional testing, the rhv was flushed with air while submerged and with the rotor cap fastened, and air bubbles were observed.The damaged seal within the rhv likely contributed to this damage and the inability to be resealed during the procedure.Penumbra accessories are 100% visually inspected and functionally tested during incoming quality inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: INDIGO SYSTEM LIGHTNING 12
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11868002
• Report Number: 3005168196-2021-01131
• Device Sequence Number: 3663368
• Product Code: QEW
• UDI-Device Identifier: 00815948022560
• UDI-Public: 00815948022560
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K202821
• 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): 04/25/2021
• 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: 12/30/2023
• Device Model Number: LITNG12XTORQ100-A
• Device Catalogue Number: LITNG12XTORQ100
• Device Lot Number: F103016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/25/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 05/22/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Date Report Sent to FDA: 01/01/2005