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

Model Number	PXSLIMLAN115T45
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the aortopulmonary collaterals using pod packing coils, a lantern delivery microcatheter (lantern), and non-penumbra catheter.During the procedure, while obtaining access through a catheter, the physician attempted to advance the lantern through a previously placed coil mass.With forward tension on the lantern, the tip prolapsed into the parent vessel.The physician was then able to successfully advance the lantern through the coil mass.The physician attempted to deliver a pod pc into the vessel, but it would not advance through the tip of the lantern.Therefore, the pod pc and the lantern were removed.It was noted that the tip of the lantern had become kinked.The procedure was completed using new pod pcs and a new lantern.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: 12354132
• Report Number: 3005168196-2021-01872
• Device Sequence Number: 4535841
• Product Code: DQY
• UDI-Device Identifier: 00814548016627
• UDI-Public: 00814548016627
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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): 08/23/2021
• 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: 03/28/2024
• Device Model Number: PXSLIMLAN115T45
• Device Catalogue Number: PXSLIMLAN115T45
• Device Lot Number: F104931
• 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: 08/05/2021
• Initial Report FDA Received Date: 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Date Report Sent to FDA: 01/01/2005