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

Model Number PXSLIMLAN135STR

Device Problems Failure to Advance (2524); Physical Resistance/Sticking (4012)

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

Event Date 06/15/2021

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.

Event Description

The patient was undergoing a coil embolization procedure in the subclavian artery using a lantern delivery microcatheter (lantern), a non-penumbra angiographic catheter and guidewire.During the procedure, the distal end of the lantern was caught in the hub of the angiographic catheter.Therefore, the physician replaced the angiographic catheter with a new angiographic catheter.Afterwards, the same issue occurred, the distal end of the lantern was caught in the hub of the new angiographic catheter.Therefore, the lantern was removed.The procedure was completed using a new lantern and the second angiographic catheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned lantern revealed that the distal shaft was ovalized.If the lantern is forcefully gripped or pinched during use, damage such as an ovalization may occur.During the functional test, resistance was encountered while attempting to advance the returned lantern through the hub of the returned non-penumbra catheter due to the ovalization in the distal shaft of the lantern.A demonstration lantern was advanced through the returned non-penumbra catheter without an issue.Evaluation of the returned non-penumbra catheter revealed no visible damage and a functional device.Penumbra catheters 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
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12187945
• MDR Text Key: 262194327
• Report Number: 3005168196-2021-01565
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016641
• UDI-Public: 00814548016641
• Combination Product (y/n): Y
• PMA/PMN Number: K152840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2024
• Device Model Number: PXSLIMLAN135STR
• Device Catalogue Number: PXSLIMLAN135STR
• Device Lot Number: F104603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• 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: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1