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

Catalog Number	PXSLIMLAN135STR
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
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.H3 other text: placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in a branch of the lumbar artery using a lantern delivery microcatheter (lantern) and a non-penumbra imaging catheter.It was noted that the patient¿s anatomy was moderately tortuous.During the procedure, while advancing the lantern through the imaging catheter, the physician experienced resistance, but was able to advance the lantern to the target vessel.Next, while selecting another branch of the lumbar artery, the physician noticed under contrast imaging and felt the lantern had fractured from the proximal end to the midshaft but remained connected by the inner wire.Therefore, the lantern was removed manually.It was reported that the physician had difficulty moving the lantern and that the lantern was torqued in the target vessel.The procedure was completed using a new lantern and the same imaging catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned px slim confirmed a fracture on the proximal end and multiple fractures on the mid-shaft.If the device is advanced against resistance, damage such as a kink may occur.Subsequently, if a kinked device is further manipulated against resistance, the kink may worsen to a fracture.The additional fractures may have occurred during retrieval attempts and the torquing during removal.Evaluation revealed ovalization on the distal end of the px slim.It was reported that the patient¿s anatomy was tortuous.Manipulation within the tortuous patient¿s anatomy likely contributed to the ovalization and resistance during the procedure.Penumbra catheters are 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.

• 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: 17280008
• Report Number: 3005168196-2023-00324
• Device Sequence Number: 5184322
• Product Code: DQY
• UDI-Device Identifier: 00814548016641
• UDI-Public: 814548016641
• 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): 07/25/2023
• 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: 06/07/2025
• Device Catalogue Number: PXSLIMLAN135STR
• Device Lot Number: F00001299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2023
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2022
• 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