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

Catalog Number PXSLIMLAN135T45

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2016

Event Type  malfunction  

Manufacturer Narrative

Results: an embolization coil was partially hanging out of the hub of the lantern.A penumbra investigator attempted to flush the embolization coil out of the hub of the lantern, but the embolization coil could not be removed.Therefore, the lantern could not be functionally tested.Conclusions: evaluation of the lantern revealed an embolization coil was stuck inside the hub and could not be removed.Therefore, the lantern could not be functionally tested.Evaluation of the first and second ruby coils revealed the pusher assembly mid-joints were retracted proximal to the introducer sheath friction locks.The introducer sheath friction lock inner diameter (id) is smaller than the rest of the introducer sheath, which allows the introducer sheath to properly seat on the ruby coil mid-joint.If the pusher assembly mid-joint is forcefully withdrawn beyond the introducer sheath friction lock, it is likely that resistance will be experienced by the physician upon attempting to advance the ruby coil.Evaluation of the podj coil revealed the embolization coil was compressed on its proximal end.This type of damage typically occurs due to repeated forceful advancement and retraction of the devices, and may contribute to difficulty when advancing the devices.Evaluation of the podj coil and the third ruby coil revealed the pusher assemblies were kinked.This damage likely occurred due to forceful manipulation of the devices against resistance.Further evaluation of the third ruby coil revealed the stretch resistant (sr) wire was fractured and the embolization coil was detached from the pusher assembly.Sr wire fracture typically occurs due to forceful retraction of the ruby coil against resistance, and will cause the embolization coil to detach.Since the lantern was blocked by an embolization coil and the embolization coil of the third ruby coil was detached, the root cause of the inability to advance the third ruby coil could not be determined.Lanterns are 100% visually inspected and ruby coils and podj coils are 100% functionally tested during in-process inspection.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: 3005168196-2016-01086, 3005168196-2016-01087, 3005168196-2016-01088, 3005168196-2016-01089.

Event Description

The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils, pod packing coils (podj coils) and a lantern delivery microcatheter (lantern).During the procedure, while the physician was advancing a ruby coil through the lantern, the coil was unable to fully advance out of the lantern.Therefore, the ruby coil was resheathed back into its introducer sheath and the lantern was repositioned.After rinsing the ruby coil, the physician made another attempt to advance the coil through the lantern; however, the coil was unable to advance as its introducer sheath appeared to be clotted.The physician removed this ruby coil and attempted to advance a new ruby coil through the lantern.However, this second coil was unable to advance because the lantern was clotted.Therefore, the lantern was flushed and the physician attempted to advance the second ruby coil again but the coil was unable to advance since its introducer sheath was clotted as well.The second ruby coil was then removed.Next, the physician deployed and detached a new ruby coil and a new podj coil into the aneurysm without any issues.While a new podj coil was being advanced through the lantern, the coil would not advance out of the tip of the lantern.While removing the podj coil from the lantern, the physician was unable to retract the coil back into its introducer sheath.Therefore, the podj coil was not resheathed for later use.Next, the physician attempted to advance another new ruby coil through the lantern; however, the ruby coil was unable to advance out of the lantern.While the coil was being resheathed and rinsed, it unintentionally detached.The physician then removed the lantern and completed the procedure using a new lantern and a new 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: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5831758
• MDR Text Key: 50728448
• Report Number: 3005168196-2016-01085
• 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
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: PXSLIMLAN135T45
• Device Lot Number: F67668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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: 46 YR