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

Model Number	PXSLIMLAN115T45
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
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: 3005168196-2021-02449.3005168196-2021-02450.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an endoleak via transcaval approach using a lantern delivery microcatheter (lantern) and a non-penumbra guide sheath.During the procedure, upon the initial advancement of the lantern through the guide sheath, the physician experienced resistance.Subsequently, the lantern kinked at the mid-shaft and broke.The same issue occurred with two other lanterns.Therefore, the lanterns were removed.The procedure was completed with thrombin.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: 12733874
• Report Number: 3005168196-2021-02448
• Device Sequence Number: 1388820
• Product Code: DQY
• UDI-Device Identifier: 00814548016627
• UDI-Public: 00814548016627
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• 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): 11/01/2021
• 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: 10/05/2023
• Device Model Number: PXSLIMLAN115T45
• Device Catalogue Number: PXSLIMLAN115T45
• Device Lot Number: F100832
• 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: 10/06/2021
• Initial Report FDA Received Date: 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Date Report Sent to FDA: 01/01/2005