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

Catalog Number PXSLIMLAN150T45

Device Problems Kinked (1339); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the lantern delivery microcatheter (lantern) was kinked approximately 2.5 cm from the hub and had contrast inside the hub.Conclusions: evaluation of the returned devices revealed that the stretch resistant (sr) wire of the first ruby coil evaluated was fractured.This type of damage likely occurred due to forceful retraction against resistance while re-sheathing the coil.Dried contrast on the embolization coil, inside the introducer sheath, or in the hub of the lantern may have contributed to this resistance and the unintentional detachment.Evaluation of the second returned ruby coil revealed that the pusher assembly was kinked and contrast was inside the introducer sheath with the embolization coil.This type of damage typically occurs due to improper handling during use.If the device is forcefully advanced against resistance, damage such as a kink may occur.Further evaluation of the returned device revealed that the introducer sheath had contrast inside.The root cause of the contrast found inside the introducer sheath could not be determined; however, the contrast inside the introducer sheath prevented the ruby coil from being advanced into the lantern during the functional analysis.Evaluation of the returned lantern revealed that it was kinked and the lumen had contrast inside.The kink likely occurred due to physician handling during insertion of a ruby coil, as was mentioned in the complaint.The kink in the lantern likely caused the resistance experienced while attempting to advance a new ruby coil into it.The root cause of the contrast inside the lumen of the lantern could not be determined.Penumbra coils and catheters are visually 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.This report is associated with mfr report numbers: 1.3005168196-2017-01677.2.3005168196-2017-01678.

Event Description

The patient was undergoing a coil embolization procedure to treat an endoleak using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician successfully deployed and detached a ruby coil into the target vessel using the lantern.The physician then selected another branch and attempted to advance a new ruby coil; however, the lantern moved so the physician decided to withdraw the ruby coil and use his non-penumbra guidewire to select the branch again.Upon re-sheathing the ruby coil, resistance was encountered and the ruby coil unintentionally detached as the physician was bringing back the last portion of the coil into the introducer sheath.The physician then pulled back the introducer sheath and the detached coil came out of the lantern.The physician asked his scrub technologist to make sure her gloves did not have contrast on them because he felt that the ruby coil pusher assembly was sticky and her gloves were full of contrast.The physician then chose another ruby coil and successfully deployed and detached it in the selected portion of the endoleak.After that, the physician tracked the lantern through the superior mesenteric artery (sma) to the inferior mesenteric artery (ima) to select another portion of the endoleak and successfully placed several more coils.Next, the physician accidentally kinked the lantern a few inches from the hub.While attempting to advance a new ruby coil through the kinked lantern, the physician experienced resistance and was unable to advance the coil through.Subsequently, the pusher assembly became bent.Therefore, the ruby coil was removed and the procedure was successfully completed using additional coils and the same lantern.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: 6912459
• MDR Text Key: 89617279
• Report Number: 3005168196-2017-01679
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016689
• UDI-Public: 00814548016689
• 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: Physician
• Type of Report: Initial
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/02/2019
• Device Catalogue Number: PXSLIMLAN150T45
• Device Lot Number: F69589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2016
• 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: 88 YR