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

Model Number	LITNG12HTORQ100-A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
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 portal vein using an indigo system aspiration catheter 12 (cat12), indigo system separator 12 (sep12), and non-penumbra sheath.During the procedure, the sep12 had been used for approximately 15 minutes when the cat12 became clogged.The physician removed the sep12 and noticed the bulb of the sep12 was unable to advance through the rotating hemostasis valve (rhv) smoothly but was able to advance when the rhv was completely open.The cat12 was them removed to flush out any existing clot.Once the cat12 was cleaned, it was reintroduced back into the sheath.When the cat12 was in place, the physician attempted to advance the sep12 into the opened rhv, but the sep12 would not advance.After multiple attempts, the physician requested a new rhv.Therefore, the initial rhv was removed.The procedure was completed using a new rhv and the same cat12 and sep12.It was reported that the new rhv was placed onto the cat12, and the sep12 was advanced through without difficulty.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned rhv revealed that the rotor cap and shim were detached from the rhv housing.The probable cause of this damage likely occurred due to over loosening the rhv rotor cap.This damage was not mentioned in the reported complaint.During the functional test, the rhv was re-assembled and functioned as intended.The rhv was able to be open and close without an issue.A demonstration sep12 was advanced and retracted through the returned rhv without any issue.Penumbra products 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: 12530934
• Report Number: 3005168196-2021-02133
• Device Sequence Number: 3989698
• 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: 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): 09/25/2021
• 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: 11/13/2023
• Device Model Number: LITNG12HTORQ100-A
• Device Catalogue Number: LITNG12HTORQ100
• Device Lot Number: F101963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 09/26/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Date Report Sent to FDA: 01/01/2005