MAUDE Adverse Event Report: PENUMBRA, INC. POD; HCG, KRD

Catalog Number	RBYPOD8
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pod coil confirmed that the embolization coil was detached from the pusher assembly inside the returned lantern.Evaluation revealed that the pusher assembly was fractured at the distal tip.If the pod coil is retracted against resistance, damage such as a fracture on the pusher assembly may occur.This damage contributed to the embolization coil detachment.The resistance was due to the ovalization on the returned lantern.Penumbra devices 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery using pod coils, a lantern delivery microcatheter (lantern), and a guidewire.It was noted that the patient¿s anatomy was tortuous.During the procedure, while advancing a pod coil through the lantern, the physician experienced resistance and the lantern kicked out of the target vessel outflow.The physician then attempted to push the lantern back into the target vessel; however, the lantern looped in the aneurysm before going into the outflow.The physician then pulled the lantern back to straighten it out.While attempting to advance the pod coil out of the distal end of the lantern, the physician noticed that the pod coil was stuck and decided to remove it.Upon removal, it was noticed that only the pusher assembly of the pod coil was removed and that the pod coil had unintentionally detached within the lantern.Therefore, the lantern containing the detached pod coil was removed.The procedure was completed using a new pod coil and a second lantern.There was no report of an adverse effect to the patient.

• Brand Name: POD
• Common Device Name: HCG, KRD
• 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: 18947565
• Report Number: 3005168196-2024-00094
• Device Sequence Number: 8161479
• Product Code: HCG
• UDI-Device Identifier: 00814548019635
• UDI-Public: 814548019635
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2024
• 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 Catalogue Number: RBYPOD8
• Device Lot Number: C00002729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• 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: 02/21/2024
• Initial Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2020
• 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 Age: 85 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005