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

Catalog Number	PXSLIMLAN135STR
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Additional 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: 1.3005168196-2023-00316.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery using a lantern delivery microcatheter (lantern), ruby coils, and a non-penumbra guide catheter.During the procedure, while advancing the lantern through the guide catheter, the physician kinked the proximal end of the lantern.Subsequently, the physician noticed that the lantern was broken before exiting the distal end of the guide catheter.It was reported that the lantern broke but was still connected.The physician then removed the lantern from the sheath by pulling it out and advanced a new lantern through the guide catheter.However, the second lantern also kinked and broke at the proximal end.Therefore, the second lantern was removed from the sheath by pulling it out.It was reported that a guidewire was not used in the lantern.The procedure was completed using a non-penumbra microcatheter, the same guide catheter, and two ruby coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned lantern confirmed that the catheter was fractured.This typically occurs if the lantern is advanced against resistance and the device becomes kinked and subsequently fracture.Evaluation also revealed ovalization near the distal tip of the catheter.This damage may occur if the peelable sheath is not utilized properly during advancement.The distal tip of the lantern may become ovalized if the distal tip of the catheter is pinched or gripped.This ovalization may have contributed to resistance during advancement.The complaint stated that a guidewire was not used during advancement of the lantern.This likely also contributed to the kink and subsequent fracture during advancement.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.This report is associated with mfr report number: 1.3005168196-2023-00316.

• 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: 17248342
• Report Number: 3005168196-2023-00315
• Device Sequence Number: 5260140
• Product Code: DQY
• UDI-Device Identifier: 00814548016641
• UDI-Public: 814548016641
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K152840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2023
• 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: 04/18/2026
• Device Catalogue Number: PXSLIMLAN135STR
• Device Lot Number: F00006411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2023
• 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: 06/08/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• 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: Male
• Date Report Sent to FDA: 01/01/2005