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

Catalog Number	400SWPC45
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
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 middle meningeal artery (mma) using swiftpac coils (swiftpac), a midway 43 delivery catheter (midway 43), non-penumbra microcatheters, and a guidewire.During the procedure, the physician successfully placed two swiftpac coils.While advancing the next swiftpac coil through the microcatheter, the physician kinked the swiftpac coil pusher assembly.Subsequently, the swiftpac coil unintentionally detached partially in the microcatheter, and partially in the patient¿s vessel.Therefore, the physician removed the microcatheter from the patient.A new microcatheter and a stent retriever were advanced to attempt to remove the detached swiftpac coil.While retracting the stent retriever, the swiftpac coil fractured inside the microcatheter and the remaining part of the coil remained in the patient¿s mma.The physician then used the microcatheter to push the swiftpac coil to the desired location in the vessel.The procedure was completed using additional swiftpac coils, and the first non-penumbra 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 Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 20328586
• Report Number: 3005168196-2024-00331
• Device Sequence Number: 9628219
• Product Code: HCG
• UDI-Device Identifier: 00815948029576
• UDI-Public: 00815948029576
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K230284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2024
• Report Date (Section F): 01/01/2005

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: 400SWPC45
• Device Lot Number: F00011544
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2024
• 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 Age: 89 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005