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

Catalog Number PXSLIMLAN135STR

Device Problems Fracture (1260); Unraveled Material (1664)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2023

Event Type  malfunction  

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 Description

The patient was undergoing a coil embolization procedure in the splenic vein using a lantern delivery microcatheter (lantern), ruby coils, a non-penumbra guide catheter and a guidewire.During the procedure, the physician implanted three ruby coils in the target location using the lantern.While attempting to remove the pusher assembly of the last coil from the lantern, the physician noticed that the proximal end of the lantern was fractured and the mid-shaft was unraveled.It was reported that the lantern was fractured but remained connected by a thread.Therefore, the physician removed the lantern by pulling it out.The procedure ended at this point and the vessel was completely embolized.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned lantern confirmed that the catheter was fractured.Evaluation revealed that the support coil winds were exposed at the fractured location.If the lantern is retracted at an angle, damage such as a kink and subsequent fracture may occur.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
• Type of Device: 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: 17446183
• MDR Text Key: 320309203
• Report Number: 3005168196-2023-00369
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016641
• UDI-Public: 814548016641
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/23/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: PXSLIMLAN135STR
• Device Lot Number: F00002431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 08/10/2023
• Supplement Dates FDA Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male