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

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2016

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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2016-00355, 3005168196-2016-00356, 3005168196-2016-00357, 3005168196-2016-00358, 3005168196-2016-00359.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure for a type ii endoleak using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced another manufacturer's sheath into the patient and inserted another manufacturer's guide catheter through it.The physician then advanced a lantern delivery microcatheter (lantern) through the guide catheter and attempted to deploy four ruby coils into the aneurysm sac; however, the coils would not advance through the lantern and were removed.Next, the physician decided to replace the lantern with another manufacturer's microcatheter and attempted to advance a new ruby coil through this microcatheter; however, this ruby coil also had difficulty advancing through the microcatheter at the same point as the first two ruby coils and therefore, it was removed.The procedure was completed using another manufacturer's coils.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 (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5523981
• MDR Text Key: 41127808
• Report Number: 3005168196-2016-00360
• 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
• Type of Report: Initial
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• 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?: No
• Date Manufacturer Received: 02/24/2016
• 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: 75 YR