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

Catalog Number PXSLIMLAN135T45

Device Problems Mechanical Problem (1384); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2018

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 manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a coil embolization procedure in the splenic artery using a lantern delivery microcatheter (lantern).It was noted that the patient's anatomy was tortuous.During the procedure, the physician advanced a lantern through a sheath up to the target vessel.While attempting to advance ruby coil through the lantern, the physician experienced resistance and the ruby coil would not advance; therefore, the ruby coil was re-sheathed and the lantern removed.Upon inspection of the lantern after removal, it was noticed that the it was kinked.The procedure was completed using the same sheath, a new lantern and the same ruby coil.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: 7961630
• MDR Text Key: 123715957
• Report Number: 3005168196-2018-02017
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016658
• UDI-Public: 00814548016658
• Combination Product (y/n): Y
• 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: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2021
• Device Catalogue Number: PXSLIMLAN135T45
• Device Lot Number: F82916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 09/13/2018
• Initial Date FDA Received: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR