MAUDE Adverse Event Report: PENUMBRA, INC. POD; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	RBYPODJ45-A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: during embolization when using coils-pulled coil from packaging and end that is used to detached coil was bent.

• Brand Name: POD
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): PENUMBRA, INC.; 630 roseville parkway; roseville CA 95747
• MDR Report Key: 22769837
• Report Number: 22769837
• Device Sequence Number: 9185228
• Product Code: HCG
• UDI-Device Identifier: 00814548017662
• UDI-Public: (01)00814548017662
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2025
• Report Date (Section F): 08/05/2025

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 Model Number: RBYPODJ45-A
• Device Catalogue Number: RBYPODJ45
• Device Lot Number: F00015683
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Date Report Sent to FDA: 08/05/2025