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

Model Number PXSLIMLAN150T45

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 02/26/2021

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 pulmonary artery using a lantern delivery microcatheter (lantern), ruby coils, and pod packing coils (pod pcs).It should be noted that the patient's anatomy was tortuous.During the procedure, the physician successfully implanted five ruby coils and three pod pcs into the target location.While advancing the next ruby coil through the hub of the lantern, the physician encountered resistance.The ruby coil was removed smoothly from the lantern and set aside; and the lantern was completely removed from the procedure.The procedure was completed using a new lantern to successfully implant the same ruby coil, as well as four additional ruby coils and six pod pcs.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned lantern revealed no issue with the hub of the catheter.Therefore, the reported hub issue could not be determined.Further evaluation revealed ovalization in the distal shaft.This damage was incidental to the reported complaint.During the functional test, a demonstration coil was advanced through the hub of the returned lantern without an issue.Resistance was then encountered as the demonstration coil became stuck at the ovalized location in the distal shaft, and the coil could not be advanced any further.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of resistance experienced at the hub while advancing the ruby coil.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: 11586005
• MDR Text Key: 242976520
• Report Number: 3005168196-2021-00627
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016689
• UDI-Public: 00814548016689
• 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: 01/01/2005,03/01/2021

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: 11/24/2023
• Device Model Number: PXSLIMLAN150T45
• Device Catalogue Number: PXSLIMLAN150T45
• Device Lot Number: F102300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• 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: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR