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

Catalog Number	RBYPODJ30
Medical Device Problem Codes	Fracture (1260); Premature Separation (4045)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
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 to treat an endoleak using a ruby coil, a pod packing coil (packing coil), a lantern delivery microcatheter, a non-penumbra glide catheter, and a sheath (6fr).During the procedure, the physician successfully implanted a ruby coil in the target location.While advancing a packing coil into the target location, the embolization coil became tangled with the previously placed coil.While retracting the packing coil, the embolization coil unintentionally detached within the lumbar artery extending to the internal iliac artery and partially within the lantern.The physician attempted to push the remaining coil into the vessel using the coil's pusher assembly, but the coil would not move.Saline was injected into the lantern to push the detached coil into the target vessel; however, it would not move.The lantern was removed from the patient and a guide wire was advanced through the glide catheter which was already positioned within the lumbar artery near the target location.The physician attempted to push the coil into the vessel using the guidewire but the coil would not move.The physician then removed the glide catheter under aspiration.After removing the glide catheter, the embolization coil was noted outside the sheath.The physician pulled the coil out by hand and the coil fractured.It was reported that most of the embolization coil was within the target endoleak sack with the remaining portion within the small branch of the internal iliac artery.The physician determined the coil was safe to be left in the internal iliac artery.The procedure was considered completed at this point.

• Brand Name: POD PACKING 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: 22917075
• Report Number: 3005168196-2025-00279
• Device Sequence Number: 21358946
• Product Code: HCG
• UDI-Device Identifier: 00814548017655
• UDI-Public: 00814548017655
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K170852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 08/28/2025

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: RBYPODJ30
• Device Lot Number: F00017214
• 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: 08/06/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2025
• 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