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

Model Number	PXSLIMLAN115T90
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using a lantern delivery microcatheter (lantern) and a guidewire.During the procedure, the physician decided to remove the lantern from the patient and encountered resistance during retraction.After the lantern was removed, the physician noticed that the distal tip of the lantern had unraveled.Therefore, the lantern was no longer used in the procedure.The procedure was completed using another lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the lantern was fractured approximately 113.0 cm from the hub.The liner within the microcatheter was stretched approximately 1.0 cm distal to the fracture.During functional testing, a demonstration guidewire was unable to be advanced through the lantern due to damaged liner on the distal tip.Conclusions: evaluation of the returned lantern confirmed a distal tip fracture and revealed that the liner within the microcatheter was stretched.If the device is forcefully retracted against resistance, damage such as this may occur.The root cause of resistance experienced during the procedure could not be determined.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
• MDR Report Key: 10939914
• Report Number: 3005168196-2020-02166
• Device Sequence Number: 13613391
• Product Code: DQY
• UDI-Device Identifier: 00814548016634
• UDI-Public: 00814548016634
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 11/03/2020
• 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: 09/01/2023
• Device Model Number: PXSLIMLAN115T90
• Device Catalogue Number: PXSLIMLAN115T90
• Device Lot Number: F99928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 01/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005