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

Catalog Number	400SWPC03
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned swiftpac coil (swiftpac) pusher assembly revealed that the pet lock was separated, the pull wire was retracted, and the embolization coil was detached.This typically occurs during a successful detachment.The detached embolization coil was not returned for evaluation.Based on the reported complaint, the root cause of the detachment issue during the procedure could not be determined.Further evaluation revealed kink on the pusher assembly.This damage was incidental to the complaint and may have occurred during packaging 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 middle meningeal artery (mma) using swiftpac coils, (swiftpac), swift coil detachment handles (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced a swiftpac into the target location and used the swift handle to detach the embolization coil.However, when the physician went to remove the pusher assembly, the swiftpac was still attached.The physician attempted to detach the swiftpac using a second swift handle, but the swiftpac would not detach.Therefore, the physician decided to remove the swiftpac.While retracting the embolization coil back into the microcatheter, the swiftpac had unintentionally detached within the microcatheter.The physician then used a guidewire to push the detached swiftpac successfully into the mma trunk.It was reported that the same issue had occurred after placing a second swiftpac and attempting to detach it using the first swift handle.While removing the swiftpac, the embolization coil had unintentionally detached within the microcatheter.The physician used the same guidewire to push the detached swiftpac into the mma trunk.The procedure was completed using two additional swiftpacs and the second swift handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed and on the initial mfr report and is being corrected on this follow-up mfr report: 1.Section h box 10.Related report numbers.

• Brand Name: SWIFTPAC 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 menezes ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 24569080
• Report Number: 3005168196-2026-00063
• Device Sequence Number: 9500156
• Product Code: HCG
• UDI-Device Identifier: 00815948024779
• UDI-Public: 00815948024779
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K230284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 04/24/2026

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: 400SWPC03
• Device Lot Number: F00019336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2025
• 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