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

Model Number PXSLIMLAN135T45

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 06/07/2021

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.This report is associated with mfr report number: 3005168196-2021-01500.

Event Description

The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using a lantern delivery microcatheter (lantern) and ruby coils.It should be noted that the patient's anatomy was tortuous.During the procedure, the physician encountered resistance while advancing the first ruby coil through the middle of the lantern.Therefore, the ruby coil was removed.While advancing the next ruby coil through the same location in the lantern, resistance was encountered.Therefore, the ruby coil and lantern were removed from the patient.The procedure was completed using another lantern to implant the same ruby coil and three pod packing coils (pod pcs).There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned lantern revealed kinks on the midshaft.If the device is manipulated against resistance or is otherwise mishandled at extreme angles during use, damage such as this may occur.During functional testing, a demonstration ruby coil could not be advanced through the lantern due to the kinks on the midshaft.The kinks likely contributed to the resistance during the procedure and the functional test.Further evaluation of the device revealed distal shaft ovalization.This damage was likely incidental to the complaint.Evaluation of the returned ruby coil revealed that the pusher assembly was fractured, and the embolization coil was detached from the pusher assembly.If the device is forcefully advanced against resistance, the pusher assembly may kink and fracture, causing the embolization coil to detach from the pusher assembly.Penumbra catheters and coils 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.This report is associated with mfr report number: 1.3005168196-2021-01500 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: 12139761
• MDR Text Key: 261479557
• Report Number: 3005168196-2021-01499
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016658
• UDI-Public: 00814548016658
• 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: 01/01/2005,07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2022
• Device Model Number: PXSLIMLAN135T45
• Device Catalogue Number: PXSLIMLAN135T45
• Device Lot Number: F94593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• 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: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR