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	11/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 left middle meningeal artery (mma) using swiftpac coils (swiftpacs), a swift coil detachment handle (handle), a benchmark 6f 071 delivery catheter (benchmark), a midway 43 delivery catheter (midway 43), a non-penumbra microcatheter, and a guidewire.During the procedure, the physician advanced the microcatheter over the guidewire.It was reported that the distal end of the guidewire fractured in the mma and will not be removed.The physician then advanced a swiftpac into the target location and placed the swiftpac into the target location using the handle.It was noted that the detachment zone was separated.While retracting the swiftpac pusher assembly, the swiftpac remained intact to the pusher assembly.The physician then advanced the swiftpac back into target location and manually detached the swiftpac into the target location.The guidewire was then exchanged for another guidewire and was advanced through the microcatheter to the different branch of the mma.While advancing a second swiftpac into the target location through the microcatheter, the physician experienced resistance and noticed that the swiftpac had unintentionally detached under fluoroscopy.It was reported that the majority of the swiftpac was in the target location.The physician then used the pusher assembly to push the remaining swiftpac into the target location.The procedure was completed using a third swiftpac, the same handle, the same benchmark, the same midway 43, and the second guidewire.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: 20870161
• Report Number: 3005168196-2024-00407
• Device Sequence Number: 8776502
• Product Code: HCG
• UDI-Device Identifier: 00815948029545
• UDI-Public: 00815948029545
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K230284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/06/2024

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: F00013128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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