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

Catalog Number PXSLIMLAN150STR

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2017

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2017-02027, 3005168196-2017-02028, 3005168196-2017-02029, 3005168196-2017-02040.

Event Description

The patient was undergoing a coil embolization procedure in the splenic artery using lantern delivery microcatheters (lanterns), ruby coils and pod packing coils (podjs).During the procedure, the physician placed an unknown manufacturer's 5f guide catheter in the target vessel, then advanced a lantern through the catheter.It was reported that the tip of the lantern was inside the aneurysm but very close to the tip of the guide catheter.The lantern was then manually flushed and a ruby coil was successfully deployed and detached without any issue.While attempting to advance a new ruby coil through the lantern, the physician experienced resistance and subsequently, the ruby coil became stuck inside the lantern.Therefore, the physician decided to remove the lantern and ruby coil altogether.The physician then advanced a new lantern into the target vessel and used a continuous flush this time.However, while attempting to advance two podjs through the new lantern, resistance was encountered and subsequently, the podjs became stuck inside the new lantern.Therefore, the lantern and both coils were removed.The procedure was completed using the same guide catheter, a non-penumbra microcatheter, five ruby coils and three podjs.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the distal tip of the first returned delivery microcatheter lantern (lantern) was repeatedly ovalized.Conclusions: evaluation of the returned lantern revealed multiple ovalizations on the distal 5cm of the catheter.These damages were likely caused by advancing the device against resistance.If a guidewire is not used this type of damage is more likely to occur.A demonstration coil was advanced through the returned lantern without issue.If the lantern ovalizations were temporarily ovalized to further extent, they may have contributed to the resistance experience while advancing ruby coils during the procedure.Evaluation of the first returned ruby coil revealed the embolization coil was detached and the pusher assembly was kinked and fractured.These damages were likely a result of forcefully advancing the device against resistance.If the pusher assembly becomes fractured it will allow the pull wire to retract from the ddt, effectively detaching the embolization coil.Further evaluation revealed damaged sections on the embolization coil.These damages were likely a result of repeated manipulation when the coil was stuck protruding from the catheter tip.There was no damage observed on the second lantern used in the procedure.A demonstration coil was advanced through the device without issue.Evaluation of the returned pod packing coils (podjs) revealed detached embolization coils.Both of the embolization coils were detached via sr wire fractures.This damage is likely a result of retracting the devices against resistance.If the embolization coil was partially out of the tip of the catheter it may have become pinned in a way that could have contributed to this resistance.Further evaluation revealed kinks on the pusher assembly.These were likely incidental and occurred during packaging for return to penumbra.Penumbra catheters and coils are inspected during in-process inspection and during quality inspection after manufacturing.This report is associated with mfr report numbers: 3005168196-2017-02027, 3005168196-2017-02028, 3005168196-2017-02029, 3005168196-2017-02040.

• 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: 7046512
• MDR Text Key: 93181929
• Report Number: 3005168196-2017-02030
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016672
• UDI-Public: 00814548016672
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K152840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/29/2019
• Device Catalogue Number: PXSLIMLAN150STR
• Device Lot Number: F73447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2016
• 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: 65 YR