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

Catalog Number	PXSLIMLAN135T45
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure using a lantern delivery microcatheter (lantern) and penumbra coils.During the procedure, the lantern broke after placing the last coil.It was reported that two halves of the lantern were connected and the lantern was removed by pulling out.The procedure was completed at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Please note that this complaint was submitted to the fda by the user facility with the following reference number: (b)(4).The following sections are being updated based on additional information included in the user facility report submitted to the fda: 1.Section e.Box 4.Initial reporter also sent report to fda.2.Section g.Box 3.Report source.Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report.1.Section b.Box 3.Date of event evaluation of the returned lantern confirmed a fracture and revealed kinks near the fractured location.If the lantern is manipulated at extreme angles during use, damage such as kinks may occur.Further manipulation of the kinked device may result into a fracture.Further evaluation of the device revealed that the distal shaft was ovalized in multiple locations.Based on the reported event, this damage was likely incidental to the complaint.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.H3 other text : placeholder.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Common Device Name: 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: 15835369
• Report Number: 3005168196-2022-00548
• Device Sequence Number: 5391231
• Product Code: DQY
• UDI-Device Identifier: 00814548016658
• UDI-Public: 814548016658
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K152840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2022
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/05/2025
• Device Catalogue Number: PXSLIMLAN135T45
• Device Lot Number: F00001931
• 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 to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005