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

Model Number	LITNG12HTORQ100-A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2021
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) and guidewire.During the procedure, the physician advanced a cat12 over a guidewire to the target vessel.Afterwards, the physician removed the guidewire and initiated aspiration.Subsequently, it was noticed that there was an air leak on the rotating hemostasis valve (rhv) of the cat12.Consequently, air was being sucked into the lightning aspiration tubing (lightning).Therefore, the rhv was removed.The procedure was completed using a new rhv, the same cat12 and the same lightning.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned rhv revealed a functional accessory.Therefore, the root cause of the reported complaint could not be confirmed.During the functional test, while attempting to loosen and tighten the rotor cap, the cap popped off.The rotor cap was re-attached to the rhv body.The rhv was then plugged and pressurized with a syringe with air, while being submerged in decontamination solution and no air bubbles were observed.Penumbra devices are visually 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
• MDR Report Key: 11958602
• Report Number: 3005168196-2021-01277
• Device Sequence Number: 1376814
• Product Code: QEW
• UDI-Device Identifier: 00815948022553
• UDI-Public: 00815948022553
• 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): 07/01/2021
• 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: 10/20/2023
• Device Model Number: LITNG12HTORQ100-A
• Device Catalogue Number: LITNG12HTORQ100
• Device Lot Number: F101284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/15/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005