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

Catalog Number	400SWPC10
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	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned swiftpac coil (swiftpac) confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the pet lock was intact, the pull wire was retracted from its alignment feature and extended beyond the distal tip of the pusher assembly, the embolization coil was detached and had offset coil winds.If the swiftpac coil is advanced against resistance during use, damage such as offset coil winds may occur.Additional resistance may be encountered due to the offset coil winds, if the device is retracted through a non-penumbra microcatheter.If the swiftpac coil is retracted against this resistance, the pusher assembly may elongate beyond the reach of the pull wire and result in the embolization coil detaching.Based on the reported complaint, the root cause of the initial resistance during the advancement 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 middle meningeal artery (mma) using swiftpac coils (swiftpacs), a non-penumbra microcatheter, an angiographic catheter, and a non-penumbra sheath.During the procedure, the physician placed the angiographic catheter in the right external carotid artery then advanced the microcatheter to the target site.While advancing a swiftpac through the microcatheter, the physician experienced resistance and the swift pac became stuck.The physician attempted to advance the swiftpac through the microcatheter, but was unsuccessful and decided to remove the swiftpac.After removing the swiftpac, it was noted that the embolization coil was not attached to the pusher assembly.The microcatheter was removed from the patient and noticed the embolization coil had unintentionally detached within the microcatheter.The procedure was completed with additional swiftpacs and a new microcatheter.There was no report of an adverse effect to the patient.

• 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 farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 22350583
• Report Number: 3005168196-2025-00222
• Device Sequence Number: 20964228
• Product Code: HCG
• UDI-Device Identifier: 00815948029545
• UDI-Public: 00815948029545
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K230284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2025

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: 400SWPC10
• Device Lot Number: F00016328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2025
• 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 Age: 73 YR
• Patient Sex: Male