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

Catalog Number	400SWPC30
Medical Device Problem Codes	Fracture (1260); Premature Separation (4045)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation of the returned swiftpac coil (swiftpac) confirmed that the embolization coil was detached and fractured.This type of damage may occur if the swiftpac is manipulated against resistance.Evaluation revealed that the pet lock was intact, pusher assembly was fractured, and the pull wire was retracted from its original position on the distal end of the pusher assembly.If the device is manipulated against resistance, damage such as a kink and subsequent fracture of the pusher assembly may occur.If the pull wire is retracted the embolization coil will detach.Based on the reported event, the coil fracture may have occurred during snaring of the detached coil.Further evaluation revealed multiple kinks along the length of 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.
Event or Problem Description
The patient was undergoing an embolization procedure in the middle meningeal artery (mma) using a benchmark 6f 071 delivery catheter (benchmark), a swiftpac coil (swiftpac), a liquid embolic agent, a non-penumbra catheter, and a non-penumbra microcatheter.During the procedure, the liquid embolic agent was placed in the distal frontal branch of the mma.The physician began to advance the swiftpac out of the microcatheter into the parietal and frontal branch of the mma.As the swiftpac was being positioned, the physician lost feedback and the swiftpac did not respond to force on the pusher wire.Fluoroscopic imaging revealed that the swiftpac was in the main trunk of the mma to the external carotid artery (eca).The physician then removed the microcatheter and the benchmark under aspiration to try and remove the detached swiftpac.The pusher was also removed.A fractured proximal swiftpac piece was noted to be in the internal carotid artery (ica).The physician removed the proximal swiftpac piece using a snare device.The physician decided to leave the distal piece of the swiftpac in place.The procedure ended at this point.

• 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: 22768157
• Report Number: 3005168196-2025-00259
• Device Sequence Number: 9574572
• Product Code: HCG
• UDI-Device Identifier: 00815948029569
• UDI-Public: 00815948029569
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 400SWPC30
• Device Lot Number: F00015701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 08/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male