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

Catalog Number PXSLIMLAN150STR

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

Results: the returned lantern had liner damage and was punctured at approximately 147.0 cm from the hub.The device had ovalizations at approximately 148.0 cm and 150.0 cm from the hub.During functional testing, a 0.025¿ mandrel was inserted approximately 1.0 cm into the catheter from the distal tip and flushed through with air while the catheter was submerged in the water.The air leak was observed at approximately 147.0 cm from the hub conclusions: evaluation of the returned lantern confirmed that the catheter lumen was punctured near the proximal markerband.During the functional testing, air leaking was observed from the damaged location.If a guidewire is forcefully advanced through a portion of the lantern with damaged liner and offset coil winds, the guidewire may puncture the catheter lumen.The liner damage and offset coil winds may have been due to repeated manipulations of the guidewire and catheter in attempt to reach target anatomy.The root cause of the internal catheter damage could not be determined.Further investigation revealed that the catheter had ovalizations on its distal shaft.Those ovalizations were likely incidental to report complaint and may have occurred during packaging for returned to penumbra.Penumbra 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.

Event Description

The patient was undergoing a coil embolization procedure in the hepatic artery using a lantern delivery microcatheter (lantern).During the procedure, the physician was advancing the lantern over a guidewire into the target vessel and noticed that the guidewire was going extraluminal.The physician then removed the lantern from the patient and found a small hole adjacent to the proximal marker.The lantern was therefore set aside and was no longer used in the procedure.The procedure was completed using another lantern and eight penumbra coils.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: 8422914
• MDR Text Key: 138893331
• Report Number: 3005168196-2019-00469
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016672
• UDI-Public: 00814548016672
• Combination Product (y/n): Y
• 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: 01/01/2005,02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2021
• Device Catalogue Number: PXSLIMLAN150STR
• Device Lot Number: F83803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2018
• 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: 83 YR