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

Catalog Number	RBYPODJ60
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pod packing coil's pusher assembly confirmed that the pusher assembly was fractured inside the introducer sheath and the embolization coil was detached.Evaluation revealed that the pull wire was retracted out of the pusher assembly distal detachment tip.If the packing coil is advanced against resistance, damage such as a kink and subsequent fracture on the pusher assembly may occur.The pusher assembly fracture likely contributed the pull wire to retract from the pusher assembly distal detachment tip, causing the embolization coil to detach during the procedure.The detached embolization coil was not returned for evaluation.The reported mildly tortuous and calcified anatomy may have contributed to the resistance during the procedure.Further evaluation revealed that the pusher assembly was kinked throughout its length.This damage was incidental to the complaint and likely occurred during packaging for returned 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 internal iliac artery (iia) using a pod packing coil (packing coil) and non-penumbra microcatheter.It should be noted that the patient's anatomy was mildly tortuous and mildly calcified.During the procedure, the physician successfully implanted one non-penumbra coil into the target vessel using the microcatheter.While advancing the packing coil through the microcatheter, the packing coil stopped advancing at the distal end of the microcatheter.While attempting to remove the packing coil, the coil unintentionally detached with most of the coil within the microcatheter.Therefore, the microcatheter containing the detached packing coil was removed.It was reported that the pusher assembly may have fractured while applying force to advance the coil.The procedure was completed using a new packing coil.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: 22195473
• Report Number: 3005168196-2025-00199
• Device Sequence Number: 20972997
• Product Code: HCG
• UDI-Device Identifier: 00814548017679
• UDI-Public: 00814548017679
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2025

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: RBYPODJ60
• Device Lot Number: F00011593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2025
• Initial Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• 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 Sex: Unknown