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

Model Number PXSLIMLAN150STR

Device Problems Break (1069); Physical Resistance/Sticking (4012)

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

Event Date 04/19/2021

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a medical procedure in the internal iliac/hypogastric artery using a lantern delivery microcatheter (lantern), a base catheter, a 6f sheath, and a guidewire.During the procedure, the physician advanced the lantern over the guidewire into the target vessel.The physician then performed a few power injections through the lantern to visualize the vessel.Next, the physician attempted to advance the lantern further.While re-inserting the guidewire into the lantern, the physician experienced resistance, and subsequently, the lantern would not advance further.Therefore, the physician decided to remove the lantern and the guidewire.However, while removing the lantern, the physician experienced resistance and pulled the lantern with force.Upon removal of the entire lantern, the physician noticed that the lantern was broken at the distal end.The procedure was completed using another catheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned lantern confirmed that the catheter was fractured.Fracture typically occurs due to manipulation against resistance.Based on the reported event, the catheter was being manipulated against resistance within the patient anatomy while re-inserting a guidewire and upon removal of the lantern.This likely contributed to the fracture during the procedure.The root cause of resistance could not be determined.Penumbra devices 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: 11842395
• MDR Text Key: 251200516
• Report Number: 3005168196-2021-01076
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016672
• UDI-Public: 00814548016672
• Combination Product (y/n): Y
• PMA/PMN Number: K152840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2022
• Device Model Number: PXSLIMLAN150STR
• Device Catalogue Number: PXSLIMLAN150STR
• Device Lot Number: F94074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• 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: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR