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

Catalog Number PXSLIMLAN150T45

Device Problems Break (1069); Fracture (1260); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2016

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure to treat a peroneal arteriovenous malformation (avm) using lantern delivery microcatheters (lantern).During the procedure, the physician lost access to the peroneal avm and attempted to regain access by reinserting the lantern into the non-penumbra diagnostic catheter.However, the physician inadvertently broke the lantern and noticed that it was almost severed in half.Therefore, the lantern was removed and a new lantern was opened to continue the procedure.The physician was advised that the new lantern was too short to deploy the ruby coil but still decided to use the lantern.While attempting to deploy the ruby coil into the peroneal avm, the physician intentionally detached the ruby coil inside the diagnostic catheter and then attempted to use a syringe filled with saline to flush the coil into the avm.Consequently, the ruby coil became stuck in the diagnostic catheter and the physician was unable to remove the coil from the diagnostic catheter.Therefore, the physician removed all of the devices and decided to abort the procedure with no coils placed into the patient.There was no noticeable damage to the lantern upon removal and there was no alleged malfunction against the ruby coil.It should be noted that the physician did not use a rotating hemostasis valve (rhv) and did not maintain a continuous flush during the procedure.Additionally, 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: 6031968
• MDR Text Key: 57558853
• Report Number: 3005168196-2016-01468
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/07/2019
• Device Catalogue Number: PXSLIMLAN150T45
• Device Lot Number: F69984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2016
• 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: 80 YR