MAUDE Adverse Event Report: PENUMBRA, INC. LANTERN DELIVERY MICROCATHETER; DQY

Model Number	PXSLIMLAN115T45
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2021-00352, 3005168196-2021-00354.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using a ruby coil, a lantern delivery microcatheter (lantern), pod coils, and a non-penumbra support catheter.During the procedure, the physician advanced a ruby coil into the target vessel using the lantern and support catheter.Then, while the ruby coil started to form in the target vessel, the lantern kicked back into the support catheter and subsequently, the ruby coil, coiled off in the support catheter.Therefore, the physician decided to remove the ruby coil.Upon retraction, the physician experienced resistance and the ruby coil unintentionally detached within the lantern.Therefore, the lantern containing the detached ruby coil was removed.After removing the lantern, the physician noticed that the distal end of the lantern was kinked.Therefore, the lantern was not used for the remainder of the procedure.Afterwards, while attempting to insert a pod coil into a new lantern, the hospital technologist bent the pusher assembly of the pod coil.Therefore, the pod coil was removed.The procedure was completed using a new pod coil, the same second lantern, and a new support catheter.There was no report of an adverse effect to the patient.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11387858
• Report Number: 3005168196-2021-00353
• Device Sequence Number: 16692034
• Product Code: DQY
• UDI-Device Identifier: 00814548016627
• UDI-Public: 00814548016627
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K152840
• 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): 02/01/2021
• 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: 08/20/2023
• Device Model Number: PXSLIMLAN115T45
• Device Catalogue Number: PXSLIMLAN115T45
• Device Lot Number: F99640
• Was Device Available for Evaluation?: No
• 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: 02/01/2021
• Initial Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Date Report Sent to FDA: 01/01/2005