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

Model Number PXSLIMLAN135STR

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 03/01/2021

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: 3005168196-2021-00619.

Event Description

The patient was undergoing a coil embolization procedure in the inferior mesenteric artery (ima) using a lantern delivery microcatheter (lantern), pod packing coils (pod pcs), and pod coils.During the procedure, the physician successfully implanted a pod coil into the target location.After advancing the next pod pc into the target location, the physician began to re-position the coil by advancing and retracting it.Next, the pod pc became stuck inside the lantern when a few centimeters of the coil was advanced into the target site and a few centimeters of the coil was inside the lantern.Therefore, the lantern containing the pod pc was removed from the patient.The procedure was completed using another lantern and two additional pod pcs.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: 11585880
• MDR Text Key: 242973300
• Report Number: 3005168196-2021-00618
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016641
• UDI-Public: 00814548016641
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K152840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2023
• Device Model Number: PXSLIMLAN135STR
• Device Catalogue Number: PXSLIMLAN135STR
• Device Lot Number: F102591
• 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: 03/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2020
• 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