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

Catalog Number PXSLIMLAN150T45

Device Problems Kinked (1339); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a coil embolization procedure in the splenic artery using a lantern delivery microcatheter (lantern).During the procedure, the physician placed the lantern in the target location using a non-penumbra sheath after navigating through tortuous anatomy.However, the physician then was unable to advance a coil through the lantern and, therefore the lantern was removed.Upon removal, the physician noticed the lantern was kinked.The physician then placed a neuron 6f 070 delivery catheter (neuron 070) to address the extreme tortuosity, and the procedure was completed using a new lantern and the same sheath.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the lantern had ovalizations at approximately 145.5 cm, 147.0 cm, 148.0 cm and 149.5 cm from the hub.The device was kinked approximately 149.0 cm from the hub.The lantern could not be flushed with the bleach solution due to a clot of blood.A 0.023¿ mandrel was inserted to loosen the clot but was unable to advance.Therefore, the device could not be functionally tested.Conclusions: evaluation of the returned lantern revealed a kink on the distal end of the catheter.If the device is forcefully manipulated within tortuous anatomy, the device may become kinked.Further evaluation revealed ovalizations on the distal shaft of the catheter.If the device is forcefully gripped during attempts advance it into a parent device, the catheter may become ovalized.These damages may have contributed to the inability to advance the embolization coil during the procedure.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• 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: 7657150
• MDR Text Key: 113009770
• Report Number: 3005168196-2018-01320
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016689
• UDI-Public: 00814548016689
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/18/2021
• Device Catalogue Number: PXSLIMLAN150T45
• Device Lot Number: F82414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• 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
• Date Manufacturer Received: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR