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

Model Number	PXSLIMLAN115STR
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the lantern was kinked approximately 40.0 cm from the hub.The device was ovalized approximately 113.5 cm from the hub.Conclusions: evaluation of the returned lantern confirmed a mid-shaft kink.If the lantern is forcefully advanced through a parent catheter at an extreme angle, damage such as this may occur.This kink likely contributed to the reported resistance experienced while advancing the packing coil lps through the lantern during the procedure.During functional testing, resistance was encountered while advancing a test mandrel through the lantern due to the kink, and the test mandrel could not be advanced any further.Further evaluation of the device revealed distal ovalization.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.This report is associated with mfr report number: 3005168196-2021-00080.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the collateral vessels using packing coil lps, pod packing coils (pod pcs), and a lantern delivery microcatheter (lantern).During the procedure, the physician placed two lp coils in the target location with the lantern.When loading the subsequent coil, a packing coil lp, into the lantern, the physician experienced resistance, and the packing coil lp kinked.The packing coil lp was then removed.The physician continued with the procedure successfully using a new packing coil lp and the same lantern.However, the physician experienced resistance loading the subsequently pod packing coil and two packing coil lps.The pod packing coil and packing coil lps were then removed.At this point, the physician removed the lantern to visually inspect the lantern and observed a kink at the midshaft.Therefore, the lantern was not used for the remainder of the procedure.The procedure was completed using a new packing coil lp and non-penumbra microcatheters.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
• MDR Report Key: 11166867
• Report Number: 3005168196-2021-00079
• Device Sequence Number: 19722553
• Product Code: DQY
• UDI-Device Identifier: 00814548016610
• UDI-Public: 00814548016610
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K152840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2020
• 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: 07/14/2023
• Device Model Number: PXSLIMLAN115STR
• Device Catalogue Number: PXSLIMLAN115STR
• Device Lot Number: F98877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• 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: 12/15/2020
• Initial Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Weight: 15
• Date Report Sent to FDA: 01/01/2005