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

Catalog Number	RBYPOD4
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
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.Evaluation revealed that the pusher assembly was fractured.If the pod coil is advanced against resistance, damage such as a kink and subsequent fracture on the pusher assembly may occur.The fracture on the pusher assembly likely caused the pull wire to retract and the embolization coil to detach from the pusher assembly.Based on the reported complaint, the root cause of the resistance could not be determined.Further evaluation of the device revealed that the pusher assembly was kinked along its length and the detached embolization coil had offset coil winds along its length.This damage was incidental to the complaint and likely occurred during packaging for return to penumbra.Penumbra devices are visually 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 splenic artery using a pod coil and a lantern delivery microcatheter (lantern).During the procedure, while advancing the pod coil through the lantern, the pod coil unintentionally detached within the lantern.Therefore, the lantern containing the detached pod coil was removed.The procedure was completed using non-penumbra coils and the same lantern.There was no report of adverse effect to the patient.

• Brand Name: POD COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 21028075
• Report Number: 3005168196-2024-00426
• Device Sequence Number: 4008634
• Product Code: HCG
• UDI-Device Identifier: 00814548019598
• UDI-Public: 00814548019598
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2024

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: RBYPOD4
• Device Lot Number: F00002100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2022
• 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 Sex: Female