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

Model Number PXSLIMLAN135T45

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2020-01380.

Event Description

The patient was undergoing a coil embolization procedure in the internal thoracic artery using a pod packing coil (pod pc), lantern delivery microcatheter (lantern), non-penumbra coils, non-penumbra microcatheter, and an angiographic catheter.It was reported that the patient anatomy was tortuous.During the procedure, the physician implanted three coils in the target vessel using the non-penumbra microcatheter.Subsequently, the microcatheter was removed and replaced with the lantern.While advancing the pod pc through the mid-shaft of the lantern, the physician encountered resistance.Therefore, the lantern and pod pc were removed.The procedure was completed using additional other coils and the initial non-penumbra microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the returned lantern was ovalized at approximately 118.0 cm and 119.0 cm from the hub.Upon functional testing, a demonstration pod pc was able to be advanced through the returned lantern with resistance due to the ovalization on the lantern.Conclusions: evaluation of the returned pod pc revealed offset coil winds on the embolization coil.If the device is forcefully advanced against resistance, damage such as offset coil winds may occur.Further evaluation of the device revealed a pusher assembly kink.This damage was likely incidental to the complaint.Evaluation of the returned lantern revealed ovalizations on its mid-shaft.If the device is forcefully gripped or pinched during use, damage such as this may occur.During the functional testing, a demonstration pod pc was able to be advanced through the lantern with resistance due to the ovalization on the lantern.This ovalization may have contributed to the reported resistance experienced during the procedure while advancing the pod pc through the lantern.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 number: 3005168196-2020-01380.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10494853
• MDR Text Key: 205887911
• Report Number: 3005168196-2020-01381
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016658
• UDI-Public: 00814548016658
• Combination Product (y/n): Y
• PMA/PMN Number: K152840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2021
• Device Model Number: PXSLIMLAN135T45
• Device Catalogue Number: PXSLIMLAN135T45
• Device Lot Number: F87533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1