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

Catalog Number	PXSLIMLAN135STR
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned lantern confirmed a kink and fracture on the catheter shaft.If the lantern is torqued many times against resistance, damage such as kink and fracture may occur.Based on the reported event, this damage likely occurred when the lantern was advanced through a steep angle during the procedure, and this also likely contributed to the resistance 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.Placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the inferior mesenteric artery (ima) using a lantern delivery microcatheter (lantern), a non-penumbra catheter, and a guidewire.It should be noted that the patient''s anatomy was steeply angled near the target vessel.During the procedure, the physician successfully implanted four coils and two pod packing coils (pod pcs) into the target location.It was also reported that the lantern was torqued many times within the steeply angled anatomy and resistance was encountered during advancement.Next, while visualizing the movement of the lantern via angiogram, the physician noticed that the lantern was not responding.Subsequently, the lantern was removed from the patient.On the back table, the physician found that the lantern was kinked and fractured.The procedure was completed using a new lantern, six coils, the same catheter, and the same guidewire.There was no report of an adverse effect to the patient.

• 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: 16117673
• Report Number: 3005168196-2023-00015
• Device Sequence Number: 17540690
• Product Code: DQY
• UDI-Device Identifier: 00814548016641
• UDI-Public: 814548016641
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2023
• 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: 06/07/2025
• Device Catalogue Number: PXSLIMLAN135STR
• Device Lot Number: F00001299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2022
• 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: 12/12/2022
• Initial Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• 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