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

Model Number	LITNG12HTORQ100-A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned rhv revealed a functional accessory.During functional testing, the stopcock connected to the side port of the rhv was able to be rotated without an issue, and fluid was able to be flushed through the stopcock and rhv without an issue.Further evaluation revealed that the neck of the rhv side port was damaged.This was likely incidental to the reported complaint and the root cause could not be determined.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the iliofemoral vein using a rotating hemostasis valve (rhv) packaged with an indigo system aspiration catheter 12 (cat12).During the procedure, the cat12 was advanced to face the clot and the physician attempted to open the stopcock connected to the side port of the rhv to begin aspiration.However, after numerous attempts, the physcian was unable to open the stopcock; therefore, the rhv was removed.The procedure was completed using a new rhv and the same cat12.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM LIGHTNING 12
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11978244
• Report Number: 3005168196-2021-01308
• Device Sequence Number: 11819768
• Product Code: QEW
• UDI-Device Identifier: 00815948022553
• UDI-Public: 00815948022553
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K200771
• 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
• Report Date (Section B): 05/13/2021
• 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: LITNG12HTORQ100-A
• Device Catalogue Number: LITNG12HTORQ100
• Device Lot Number: F103015
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Date Report Sent to FDA: 01/01/2005