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

Catalog Number	PXSLIMLAN150T45
Medical Device Problem Codes	Break (1069); Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the pulmonary artery and vein using a lantern delivery microcatheter (lantern), penumbra coils (ruby/pod/packing), a non-penumbra diagnostic catheter and a guidewire.It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician successfully placed approximately four to five penumbra coils in the target location using the lantern.The physician then attempted to advance the next penumbra coil through the lantern; however, the physician experienced resistance and the penumbra coil would not advance through.Therefore, the physician decided to remove the penumbra coil and lantern.Upon removal of the penumbra coil and lantern, the physician noticed that the distal end of the lantern was unwound.Therefore, the lantern was no longer used in the procedure.The procedure was completed using a new lantern, penumbra coils and the same diagnostic catheter.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the pulmonary artery and vein using a lantern delivery microcatheter (lantern), penumbra coils (ruby/pod/packing), a non-penumbra diagnostic catheter and a guidewire.It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician successfully placed approximately four to five penumbra coils in the target location using the lantern.The physician then attempted to advance the next penumbra coil through the lantern; however, the physician experienced resistance and the penumbra coil would not advance through.Therefore, the physician decided to remove the penumbra coil and lantern.Upon removal of the penumbra coil and lantern, the physician noticed that the proximal end of the lantern was unwound.Therefore, the lantern was no longer used in the procedure.The procedure was completed using a new lantern, penumbra coils and the same diagnostic catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on clarification provided by a penumbra sales representative on 03/20/2024: 1.Section b.Box 5.Describe event or problem 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: 3005168196-2023-00563.1.Section h.Box 6.Device code 1 evaluation of the returned lantern confirmed multiple kinks and fractures along the proximal end.This type of damage typically occurs if the device is retracted against resistance or handled at an angle during removal from a procedure.Further evaluation revealed ovalization on the catheter distal end.If the device is advanced against resistance, damage such as ovalization may occur.This damage may have contributed to resistance while advancing the coil through the catheter lumen and removal of the lantern during the procedure.The reported tortuous patient anatomy also may have contributed to resistance during advancement.Penumbra devices 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.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up # 2 mfr report: 1.Section d.Box 4.Unique identifier 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: 18361944
• Report Number: 3005168196-2023-00563
• Device Sequence Number: 12705486
• Product Code: DQY
• UDI-Device Identifier: 00814548016689
• UDI-Public: 00814548016689
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K152840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2024
• 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: 05/25/2026
• Device Catalogue Number: PXSLIMLAN150T45
• Device Lot Number: F00006912
• 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: 11/21/2023
• Supplement Date Received by Manufacturer: 03/21/2024; 01/14/2005
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 04/09/2024; 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2023
• 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