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

Catalog Number	RBYPOD8
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using pod coils, a pod packing coil (packing coil), and a non-penumbra microcatheter.During the procedure, while advancing a pod coil through the microcatheter, the pod coil unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached pod coil was removed.The same issue occurred with another pod coil and a packing coil.The physician removed the microcatheter containing the detached pod coil and packing coil respectively.The procedure was completed using a new microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Please note that the following section was updated on this follow-up #01 mfr report 3005168196-2025-00214: 1.Section b.Box 5.Describe event or problem.Evaluation of the second returned pod coil confirmed that the embolization coil was detached from its pusher assembly.Evaluation revealed that the pusher assembly was fractured, and the pull wire was retracted from its initial position on the distal end of the pusher assembly.If the pod coil is advanced against resistance damage such as a kink and subsequent fracture may occur.Based on the reported complaint, the root cause of resistance could not be determined.The pusher assembly fracture likely contributed to the embolization coil detachment.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.This report is also associated with mfr report number: 1.3005168196-2025-00215.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a pod coil and a non-penumbra microcatheter.During the procedure, while advancing a pod coil through the microcatheter, the pod coil unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached pod coil was removed.It was reported that the physician was unable to implant a pod coil and a pod packing coil (packing coil) and no additional details are available.Therefore, both coils were removed.The procedure was completed using a new 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: 22325650
• Report Number: 3005168196-2025-00214
• Device Sequence Number: 8948306
• Product Code: HCG
• UDI-Device Identifier: 00814548013831
• UDI-Public: 00814548013831
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K141134
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: F93635
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2019
• 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: 50 YR
• Patient Sex: Male