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

Catalog Number	RBYPOD8
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 using pod coils and a non-penumbra microcatheter.During the procedure, it was reported that there was an issue with a pod coil.The pod coil was removed.While repositioning the next pod coil, the embolization coil unintentionally detached in the patient's vessel.A snare device was used to attempt to remove the detached embolization coil without success.No additional information was provided on how the procedure was completed.
Event or Problem Description
The patient was undergoing a coil embolization procedure using pod coils and a non-penumbra microcatheter (progreat).During the procedure, it was reported that there was an issue with a pod coil.The pod coil was removed.While repositioning the next pod coil, the embolization coil unintentionally detached in the patient's vessel.Multiple attempts were made to snare the detached embolization coil without success.The patient was taken for a computed tomography angiography (cta) which showed the detached coil in the splenic artery with the end part in the celiac ostium without obvious aortic involvement.It was reported that the patient requires repeat ct angiograms due to the detached embolization coil.
Additional Manufacturer Narrative
Please note that this complaint was also submitted to the fda by the user facility.The following sections are being updated based on additional information included in the user facility report submitted to the fda: 1.Section a.Box 2.Age, box 3a.Sex, box 4.Weight.2.Section b.Box 5.Describe event or problem.3.Section e.Box 4.Initial reporter also sent report to fda.4.Section g.Box 2.Report source.5.Section h.Box 10.Related report numbers.

• 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 menezes ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 24039108
• Report Number: 3005168196-2026-00011
• Device Sequence Number: 10482584
• Product Code: HCG
• UDI-Device Identifier: 00814548019635
• UDI-Public: 00814548019635
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RBYPOD8
• Device Lot Number: F00014938
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR
• Patient Sex: Male
• Patient Weight: 68 KG