MAUDE Adverse Event Report: PENUMBRA, INC. PAC400 COIL; HCG, KRD

Catalog Number	400PAC40
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pac400 coil confirmed that the embolization coil was detached.Evaluation revealed that the pull wire and pet bump were advanced distal within the pusher assembly distal tip.If the pac400 is advanced against resistance, the pull wire and pet bump may be forced distal into the alignment feature.This movement may have contributed to the detachment of the embolization coil during the procedure.The root cause of resistance during the procedure 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the carotid cavernous fistula (ccf) using pac400 coils and a px slim delivery microcatheter (px slim).During the procedure, the physician successfully implanted two pac400 coils into the target vessel using the px slim.While advancing another pac400 coil into the target vessel, the coil unintentionally detached partially in the vessel.Therefore, the detached pac400 coil was removed using a snare device and a guide catheter.The procedure was completed using four additional pac400 coils and two px slims.It was reported that the physician switched the pxslim 45 degree to a straight in order to reach a different part of the ccf.There was no report of an adverse effect to the patient.

• Brand Name: PAC400 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: 23043522
• Report Number: 3005168196-2025-00298
• Device Sequence Number: 10096224
• Product Code: HCG
• UDI-Device Identifier: 00815948021334
• UDI-Public: 00815948021334
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K173614
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/12/2025

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: 400PAC40
• Device Lot Number: F00011927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2024
• 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