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

Model Number PXSLIMLAN150T45

Device Problems Kinked (1339); Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2017

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 numbers: 3005168196-2017-01564, 3005168196-2017-01565.The hospital discarded the device.

Event Description

The patient was undergoing a coil embolization procedure to treat a renal arteriovenous malformation (avm) using ruby coils.It was noted that the patient had a very tortuous anatomy.During the procedure, while attempting to advance a ruby coil through a lantern delivery microcatheter (lantern), the physician experienced stiffness and subsequently, the ruby coil unintentionally detached within the lantern.Therefore, the physician removed the lantern containing the detached coil, then flushed the coil out and reinserted the lantern into the patient's body.While attempting to advance a new ruby coil through the lantern, the physician experienced stiffness again and subsequently, the ruby coil unintentionally detached within the lantern.Therefore, the physician removed the lantern containing the detached coil and flushed the coil out.The physician then discovered that the lantern was kinked.Therefore, the lantern was set aside and the procedure was completed using a new lantern and three additional ruby coils with no problem.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following section was inadvertently missed on the initial mfr report and is being included on this follow-up #01 mfr report: 3005168196-2017-01566.This report is associated with mfr report numbers: 3005168196-2017-01564 and 3005168196-2017-01565.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6865969
• MDR Text Key: 86484624
• Report Number: 3005168196-2017-01566
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/16/2020
• Device Model Number: PXSLIMLAN150T45
• Device Catalogue Number: PXSLIMLAN150T45
• Device Lot Number: F75062
• Was Device Available for Evaluation?: No
• 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: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR