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

Model Number	PXSLIMLAN150T45
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned lantern confirmed an ovalization on the distal shaft.If the distal tip is forcefully pinched or gripped during use, or if the device is manipulated at extreme angles, damage such as an ovalization may occur.This damage likely contributed to the embolization coil becoming stuck during the procedure.Evaluation of the returned pod6 confirmed that the embolization coil was detached from the pusher assembly and was stuck within the lantern.The pusher assembly was not returned for evaluation.Further evaluation revealed that the proximal constraint sphere was not present on the proximal end of the embolization coil or within the lantern.If the pod6 is forcefully retracted resistance, the stretch resistant wire may fracture, causing the embolization coil to detach.The embolization coil was unable to be removed from the lantern.Penumbra catheters and coils 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: 005168196-2021-01736.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the branches of the hypogastric artery using a lantern delivery microcatheter (lantern), a pod coil and a non-penumbra catheter.During the procedure, while attempting to advance the pod coil through the lantern, the pod coil became stuck within the lantern.Upon retraction, the pod coil unintentionally detached.Therefore, the lantern containing the detached pod coil was removed from the patient.Subsequently, upon removal, the distal portion of the lantern was observed to be kinked and ovalized.The procedure was completed using a new lantern with a straight tip, a new pod coil and the same sheath.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: 12271342
• Report Number: 3005168196-2021-01735
• Device Sequence Number: 4376729
• Product Code: DQY
• UDI-Device Identifier: 00814548016689
• UDI-Public: 00814548016689
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 08/03/2021
• 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: 12/23/2023
• Device Model Number: PXSLIMLAN150T45
• Device Catalogue Number: PXSLIMLAN150T45
• Device Lot Number: F102949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• 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: 07/08/2021
• Initial Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Date Report Sent to FDA: 01/01/2005