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

Model Number PXSLIMLAN115STR

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 03/19/2021

Event Type  malfunction  

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 number: 3005168196-2021-00757.

Event Description

The patient was undergoing a coil embolization procedure in the abdominal aortic aneurysm (aaa) sac using pod packing coils (pod pcs), a lantern delivery microcatheter (lantern), and non-penumbra diagnostic catheter.During the procedure, the physician placed two pod pcs in the target location.Subsequently, the next pod pc became stuck inside the lantern after advancing to a certain point and would not retract.It was reported the physician had advanced the diagnostic catheter without a wire and had manipulated the lantern without a wire.When attempting to pull the pod pc back, the pod pc unintentionally detached in the lantern.Therefore, the detached pod pc and lantern were removed together.The lantern was inspected, and the hospital staff noticed the lantern was kinked at the distal shaft, around the area where the pod pc was getting stuck.The procedure was completed using two new pod pcs and a new lantern.There was no report of an adverse effect to the patient.

• 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: 11668439
• MDR Text Key: 245492404
• Report Number: 3005168196-2021-00756
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016610
• UDI-Public: 00814548016610
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K152840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2023
• Device Model Number: PXSLIMLAN115STR
• Device Catalogue Number: PXSLIMLAN115STR
• Device Lot Number: F100831
• Was Device Available for Evaluation?: No
• 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
• Date Manufacturer Received: 03/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2020
• 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: 80