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

Catalog Number	RBYPOD8
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
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 in the internal iliac artery (iia) using pod coils, pod packing coils (packing coil), a non-penumbra catheter and a non-penumbra microcatheter.It should be noted that the patient¿s anatomy was mildly tortuous and mildly calcified.During the procedure, the physician experienced resistance while inserting the first pod coil into the microcatheter.The physician was unable to advance the pod coil beyond the mid-shaft of the microcatheter and fractured the pusher assembly of the pod coil.It was then found under fluoroscopy that the pod coil had unintentionally detached at the mid-shaft of the microcatheter.Therefore, the microcatheter containing the detached pod coil was removed from the patient, and the pod coil was flushed out of the microcatheter.The procedure was completed using two pod coils, three packing coils, and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by the distributor on (b)(6) 2025: 1.Section b.Box 5.Describe event or problem 2.Section h.Box 6.Medical device problem code 1 evaluation of the returned pod coil could not confirm the reported advancement issue.Evaluation revealed a functional device.During evaluation, the pod coil advanced out of its introducer sheath and through a demonstration lantern without an issue.Therefore, the root cause of the reported complaint could not be determined.Further evaluation revealed bends on the pusher assembly.This damage was incidental to the reported complaint and may have occurred during packaging of the device for return to penumbra.Penumbra coils 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.Note: based on the investigation findings, this is not considered a reportable event.This event did not and, if it were to recur, it would not cause or contribute to serious deterioration or death.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using pod coils, pod packing coils (packing coil), a non-penumbra catheter, and a non-penumbra microcatheter.It should be noted that the patient¿s anatomy was mildly tortuous and mildly calcified.During the procedure, the physician experienced resistance while inserting the first pod coil into the microcatheter.The pod coil then became stuck in the mid-shaft of the microcatheter, and would not advance further.Therefore, the microcatheter containing the pod coil was removed from the patient.The microcatheter was then flushed and the pod coil was removed intact.The procedure was completed using two pod coils, three packing coils, and the same microcatheter.There was no report of an 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: 21203587
• Report Number: 3005168196-2025-00020
• Device Sequence Number: 20872203
• Product Code: HCG
• UDI-Device Identifier: 00814548019635
• UDI-Public: 00814548019635
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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: F00011967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• 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: Unknown