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

Catalog Number	400SWPC45
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned swiftpac coil confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was intact on the proximal end of the pusher assembly, the pull wire was in its initial position within the pusher assembly distal tip and the embolization coil was detached.If the swiftpac coil is retracted against resistance during use, the pusher assembly may elongate beyond the reach of the pull wire and result in the embolization coil detaching from its pusher assembly.Based on the reported event, the root cause of the resistance could not be determined.The detached embolization coil was not returned for evaluation.Further evaluation revealed that the pusher assembly was kinked throughout its length.This damage is incidental to the reported complaint and likely occurred during packaging for return.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 a swiftpac coil (swiftpac) and a non-penumbra microcatheter.It was reported that the patient¿s anatomy was mildly tortuous.During the procedure, while attempting to place the swiftpac into the target location, the physician determined that the swiftpac was too long for the target vessel.The physician decided to remove the swiftpac for a shorter swiftpac.While retracting the swiftpac, the physician experienced resistance and noticed that the swiftpac unintentionally detached in the common carotid artery (cca).The physician then used a balloon to push the swiftpac into the external carotid artery (eca).The physician determined that the swiftpac was safe to be left inside the patient.The procedure was completed using non-penumbra coils and the same microcatheter.

• 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: 20844478
• Report Number: 3005168196-2024-00399
• Device Sequence Number: 8100117
• Product Code: HCG
• UDI-Device Identifier: 00815948029576
• UDI-Public: 00815948029576
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/03/2024

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: 400SWPC45
• Device Lot Number: F00013017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2024
• Initial Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2024
• 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: Unknown