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

Model Number PXSLIMLAN135T45

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2022

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2022-00061.

Event Description

The patient was undergoing a coil embolization procedure in the renal artery using ruby coils, a penumbra coil detachment handle (handle), a lantern delivery microcatheter (lantern), and a guidewire.During the procedure, the physician successfully implanted three non-penumbra coils and used the handle to implant two penumbra smart coils (smart coils) and two pod coils.After advancing a ruby coil into the target location, the physician attempted to detach it with the handle; however, the ruby coil did not detach.Subsequently, the ruby coil unintentionally detached inside the lantern.While using the guidewire to push the ruby coil into the target location, the physician experienced resistance; however, the ruby coil was successfully implanted.Subsequently, imaging revealed that the guidewire had perforated the lantern.Therefore, the lantern and the guidewire were removed.An angiography showed that the target vessel was sufficiently embolized; therefore, the procedure ended at this point.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned lantern confirm that the distal shaft of the catheter was punctured.This damage may have occurred while advancing the detached embolization coil into the target location using a guidewire as mentioned in the complaint.Further evaluation revealed bends in the catheter shaft.This damage was incidental to the reported complaint and the root cause could not be determined.Penumbra catheters are visually 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.H3 other text : placeholder.

• 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: 13551136
• MDR Text Key: 287550895
• Report Number: 3005168196-2022-00062
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016658
• UDI-Public: 00814548016658
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K152840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2024
• Device Model Number: PXSLIMLAN135T45
• Device Catalogue Number: PXSLIMLAN135T45
• Device Lot Number: F105585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2021
• 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