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

Catalog Number PXSLIMLAN135T45

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2017

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: 3005168196-2018-00122, 3005168196-2018-00123, 3005168196-2018-00124.

Event Description

The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician felt resistance after advancing a ruby coil (f77542) about 1.5 cm out of the tip of the non-penumbra microcatheter and into the patient, and therefore the ruby coil was retracted into the microcatheter.The physician repositioned the microcatheter and re-attempted to place the coil.This occurred about three times, and then the ruby coil unintentionally detached within the microcatheter while being manipulated.The physician therefore removed the microcatheter with the ruby coil inside.The physician then inserted a new non-penumbra microcatheter and again attempted to advance a ruby coil (f66218), however felt the same resistance while advancing out of the tip of the microcatheter, and therefore the ruby coil was removed.The physician then attempted to use a new coil, however the same resistance was felt and the physician was unable to advance the coil more than about two centimeters out of the tip of the microcatheter.The microcatheter and the coil were therefore removed.The physician then was able advance a coil through the 5fr catheter and place it, despite feeling a lot of resistance.The physician then was unable to advance another coil through the catheter, and therefore removed the coil and the catheter.The physician inserted a new 5fr catheter and re-attempted to advance the same coil, however was again unsuccessful.The physician then placed a lantern delivery microcatheter (lantern) within the 5fr catheter and attempted to advance a ruby coil (f77724).However the physician reported feeling resistance after several centimeters of the ruby coil had advanced into the aneurysm.The physician therefore attempted to retract the ruby coil, however upon retraction the ruby coil unintentionally detached.The physician used a syringe with saline to flush the ruby coil into the aneurysm.It was reported that the ruby coil appeared to break, leaving part of the ruby coil inside the lantern while part of it was implanted.The procedure ended at this point.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the lantern delivery microcatheter (lantern) was kinked approximately 2.0 cm from the distal tip.Conclusions: evaluation of the first returned ruby coil revealed the pusher assembly was fractured and the embolization coil was detached.Fracture of the pusher assembly may have occurred due to forceful manipulation against resistance of the ruby coil during re-positioning within patient anatomy.Pusher assembly fracture may allow the pull wire retract out of the ddt and allow the embolization coil to detach.Further evaluation revealed the lantern was kinked.This damage may have also occurred due to forceful manipulation during re-positioning, and likely contributed to the resistance experienced during advancement into the aneurysm.Evaluation of the second returned ruby coil revealed the embolization coil was detached and the proximal constraint sphere was intact with the coil.Since the pusher assembly was not returned for evaluation, the root cause of this unintentional detachment could not be determined.Penumbra coils and 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.This report is associated with mfr report numbers: 3005168196-2018-00122, 3005168196-2018-00123, 3005168196-2018-00124.

• 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: 7186846
• MDR Text Key: 97744748
• Report Number: 3005168196-2018-00125
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016658
• UDI-Public: 00814548016658
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/11/2019
• Device Catalogue Number: PXSLIMLAN135T45
• Device Lot Number: F67883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2016
• 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: 67 YR