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

Model Number	PXSLIMLAN150T45
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using a lantern delivery microcatheter (lantern) and non-penumbra catheter.During the procedure, the lantern broke proximally by the hub when being advanced through the catheter.Therefore, the lantern was removed.The procedure was completed using a new lantern and the same catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned lantern revealed a fracture on the midshaft.There was no visible damage near the hub area; therefore, this damage was likely the reported proximal break by the hub.If the device is forcefully advanced against resistance, damage such as a kink and subsequent fracture may occur.Further evaluation revealed ovalizations on the distal shaft.If the distal tip is forcefully pinched or gripped during use, damage such as ovalizations may occur.This damage may have 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.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: 12110937
• Report Number: 3005168196-2021-01465
• Device Sequence Number: 3705104
• Product Code: DQY
• UDI-Device Identifier: 00814548016689
• UDI-Public: 00814548016689
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• 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): 08/16/2021
• 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: 09/18/2023
• Device Model Number: PXSLIMLAN150T45
• Device Catalogue Number: PXSLIMLAN150T45
• Device Lot Number: F100348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 08/16/2021
• 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