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

Catalog Number PXSLIMLAN135T45

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2016

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 number: 3005168196-2016-00232.The hospital disposed of the device.

Event Description

The patient was undergoing a y-90 mapping procedure in the gastroduodenal artery (gda) using pod4 coils and a lantern delivery microcatheter (lantern).During the procedure, while the physician was deploying a pod4 coil into the gda, the lantern kicked out of the vessel leaving a portion of the coil in the gda.The physician attempted to reposition the lantern into the gda; however, the angio catheter dislodged from the celiac artery into the aorta and at the same time, the pod4 unintentionally detached.The physician made several attempts to retrieve the pod4 coil using a snare device but was unsuccessful and decided to leave the coil in the patient.A portion of the pod4 coil was left in the gda while the remaining segment was left in the right hepatic artery.The physician removed the lantern and continued the procedure in a small accessory vessel using another manufacturers' microcatheter and coils.The procedure was then completed after the physician injected macroaggregated albumin (maa) into the vessel.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5462014
• MDR Text Key: 39088482
• Report Number: 3005168196-2016-00233
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016658
• UDI-Public: 00814548016658
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/29/2018
• Device Catalogue Number: PXSLIMLAN135T45
• Device Lot Number: F66712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR