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

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2018

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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2018-01086, 3005168196-2018-01087.The hospital discarded the device.

Event Description

The patient was undergoing a coil embolization procedure using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician successfully deployed and detached a ruby coil in the target vessel using a lantern.While attempting to advance a new ruby coil through the lantern, the physician experienced resistance and the ruby coil would not advance; therefore, it was removed.The physician then successfully placed another ruby coil in the target vessel using the same lantern.While attempting to advance the last ruby coil, the physician experienced resistance again and the ruby coil would not advance.Therefore, the lantern and ruby coil were removed and the procedure was ended.There was no report of an adverse effect to the patient.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7552877
• MDR Text Key: 109515092
• Report Number: 3005168196-2018-01088
• Device Sequence Number: 1
• Product Code: DQY
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 74 YR