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

Model Number	PXSLIMLAN115T45
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
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 coil embolization procedure in the internal iliac artery (iia) using pod coils, a lantern delivery microcatheter (lantern), and a non-penumbra catheter.It should be noted that the patient's anatomy was tortuous and calcified.During the procedure, the physician successfully implanted one pod coil in the target location.While advancing the next pod coil, it became stuck in the middle of the lantern.Upon removal from the microcatheter, the physician inadvertently kinked the pod coil pusher wire.It was also reported that the physician inadvertently broke the lantern at approximately thirty-nine centimeters from the distal end and kinked it at approximately fifty-three centimeters from the distal end.It is unknown when the damage occurred; however, the lantern remained in one piece and was removed from the patient.The procedure was completed using another pod coil, eight pod packing coils (pod pcs), a non-penumbra microcatheter, and the same catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned lantern confirmed a fracture on the mid-shaft.If the device is manipulated against resistance or is otherwise mishandled at extreme angles during use, damage such as a kink may occur.If a kinked device is further manipulated, the damage may worsen to a fracture.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: LANTERN DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 13476810
• Report Number: 3005168196-2022-00047
• Device Sequence Number: 14818420
• Product Code: DQY
• UDI-Device Identifier: 00814548016627
• UDI-Public: 00814548016627
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2022
• 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: 09/27/2024
• Device Model Number: PXSLIMLAN115T45
• Device Catalogue Number: PXSLIMLAN115T45
• Device Lot Number: F109485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• 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: 01/12/2022
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005