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

Catalog Number PXSLIMLAN115STR

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2018

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: 3005168196-2019-00355.

Event Description

The patient was undergoing a coil embolization procedure to treat a renal arteriovenous fistula using pod packing coils (pod pcs) and a lantern delivery microcatheter (lantern).During the procedure, the physician successfully placed five penumbra smart coils (smart coils) using the lantern.The physician then felt resistance approximately five centimeters from the distal tip of the lantern while advancing another pod pc.Therefore, the lantern and pod pc were removed, and upon removal, it was found that the pod pc had punctured through the lantern.The procedure was then completed using a new lantern with a new pod pc.There was no report of an adverse effect to the patient.

Event Description

The patient was undergoing a coil embolization procedure to treat a renal arteriovenous fistula using pod packing coils (pod pcs) and a lantern delivery microcatheter (lantern).During the procedure, the physician successfully placed five penumbra coil 400s (pc 400) using the lantern.The physician then felt resistance approximately five centimeters from the distal tip of the lantern while advancing a pod pc.Therefore, the lantern and pod pc were removed, and upon removal, it was found that the pod pc had punctured through the lantern.The procedure was then completed using a new lantern with a new pod pc.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being updated on this follow-up # 01 mfr report.Results: the pod pc was inside the lantern and non-penumbra catheter.The embolization coil was protruding the lantern approximately 111.0 cm from the hub of the lantern and offset coil winds were present along the embolization coil.The lantern was punctured approximately 111.0 cm from the hub.Conclusions: evaluation of the returned pod pc and lantern confirmed the embolization coil punctured the lumen of the lantern and revealed offset coil winds within the lumen of the lantern.If the pod pc was advanced against resistance through a damaged portion of the lantern, it may contribute to the pod pc puncturing the lantern lumen.Further evaluation of the pod pc revealed offset coil winds.These offset coil winds were likely a result of advancement against resistance and puncturing the lantern lumen.The root cause of the initial resistance within the lantern 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 number: 3005168196-2019-00355.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8369933
• MDR Text Key: 137239452
• Report Number: 3005168196-2019-00354
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016610
• UDI-Public: 00814548016610
• 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: 01/01/2005,01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2021
• Device Catalogue Number: PXSLIMLAN115STR
• Device Lot Number: F83915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• 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: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1