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

Catalog Number	RBYPODJ5
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pod packing coil (packing coil) confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was undamaged and intact on the proximal end of the pusher assembly, the pull wire was in its initial position within the pusher assembly distal tip and the embolization coil was detached.If the packing coil is retracted against resistance during use, the pusher assembly may elongate beyond the reach of the pull wire and result in the embolization coil detaching from its pusher assembly.Based on the reported event, the root cause of the resistance could not be determined.Further evaluation revealed kinks along the length of the pusher assembly.This damage was incidental to the reported complaint and may have occurred during packing 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a pod packing coil (packing coil), ruby coils, a non-penumbra microcatheter, and a guidewire.During the procedure, the physician successfully implanted two ruby coils into the target vessel.The packing coil was advanced to the target location.While repositioning, the embolization coil unintentionally detached within the microcatheter.The microcatheter containing the detached packing coil was removed and flushed out of the microcatheter.The procedure was completed using another packing coil of the same size, a ruby coil, and the same microcatheter.There was no report of an adverse effect to the patient.

• 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: 22351841
• Report Number: 3005168196-2025-00223
• Device Sequence Number: 4825538
• Product Code: HCG
• UDI-Device Identifier: 00814548017631
• UDI-Public: 00814548017631
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K170852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/27/2025

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: RBYPODJ5
• Device Lot Number: F00014580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• 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 Age: 9 YR
• Patient Sex: Female