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

Catalog Number	RBYPODJ45
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	01/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 1.3005168196-2025-00059.2.3005168196-2025-00060.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right subclavian artery using a pod coil, pod packing coils (packing coil), and a lantern delivery microcatheter (lantern).During the procedure, the physician experienced resistance advancing the pod coil into the target location.To achieve better packing, the physician repositioned the lantern multiple times.While advancing and retracting the pod coil, the pod coil unintentionally detached.The pod coil was removed from the patient.The same issue occurred with three additional pod packing coils.Out of the four detached coils, three coils were detached in the lantern and were removed by removing the lantern from the patient.It was reported that one of the four coils detached partially in the vessel and partially in the microcatheter and that coil was snared out.It is unknown which of the four detached coils was snared out.The procedure was completed using additional penumbra coils and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the first returned pod packing coils (packing coil) confirmed that the embolization coil was detached.Evaluation revealed that the distal tip of the pusher assembly was fractured.If the packing coil is retracted against resistance, damage such as this may occur.The fractured distal tip on the pusher assembly likely contributed to the embolization coil detaching from the pusher assembly.Based on the reported event, the root cause of resistance could not be determined.Further evaluation revealed offset coil winds along the length of the embolization coil.This damage was incidental to the reported complaint and the root cause could not be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.

• 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: 21472180
• Report Number: 3005168196-2025-00058
• Device Sequence Number: 12967182
• Product Code: HCG
• UDI-Device Identifier: 00814548017662
• UDI-Public: 00814548017662
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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: RBYPODJ45
• Device Lot Number: F00014136
• 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: 01/31/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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: Female