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

Catalog Number	400SMTHXSFT1H02
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The embolization coil was implanted into the patient.However, the pusher assembly returned.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization in the penile artery using penumbra smart coils (smart coils), penumbra smart coil detachment handles (handles), and a microcatheter.During the procedure, the physician successfully implanted two smart coils into the target vessel using the handle.After advancing the third smart coil into the target location, the physician attempted to detach the coil using the handle; however, the coil would not detach.Therefore, the handle was removed and was no longer used in the procedure.The physician then attempted to use a second handle to detach the same smart coil; however, the coil still did not detach.While attempting to manually detach the smart coil, the coil was inadvertently pulled back into the microcatheter and detached within the distal end of the microcatheter.The physician then used the smart coil pusher assembly to successfully implant the coil into the target location.The procedure was completed using three additional smart coils, the second handle, and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned penumbra smart coil (smart coil) confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was separated on the proximal end of the pusher assembly, the pull wire was retracted on the distal end of the pusher assembly.If this occurs, the embolization coil will detach from its pusher assembly.The detached embolization coil was not returned for evaluation, and the returned condition of the device indicates a successful coil detachment attempt.Therefore, the root cause of the reported complaint cannot be determined.Further evaluation revealed kinks on the pusher assembly.This damage was incidental to the reported complaint and may have occurred during packaging 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.
Additional Manufacturer Narrative
Please note that the following sections were updated: section h.Box 6.Investigation findings 1.Section h.Box 6.Investigation conclusions 1.Section h.Box 11.Additional manufacturer narrative.Evaluation of the returned penumbra smart coil (smart coil) confirmed that the embolization coil was detached.The evaluation revealed that the pet lock was separated and the pull wire was retracted.This indicates a successful detachment attempt.If this occurs, the embolization coil will detach from its pusher assembly.The detached embolization coil was not returned for evaluation and the root cause of the difficulty detaching could not be determined.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.

• Brand Name: PENUMBRA SMART 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: 21896096
• Report Number: 3005168196-2025-00134
• Device Sequence Number: 3530520
• Product Code: HCG
• UDI-Device Identifier: 00814548015651
• UDI-Public: 00814548015651
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2025

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 Expiration Date: 01/07/2026
• Device Catalogue Number: 400SMTHXSFT1H02
• Device Lot Number: F103165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Supplement Date Received by Manufacturer: 04/25/2025; Not provided
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 05/26/2025; 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2021
• 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: 60 YR
• Patient Sex: Male