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

Catalog Number	400SWPC45
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior middle meningeal artery (mma) using a swiftpac coil (swiftpac), a neuron select catheter 6f (6f select), a non-penumbra microcatheter, a non-penumbra sheath, and a microwire.During the procedure, the physician successfully placed two swiftpacs into the target vessel.The physician then advanced a third swiftpac three fourth of the way into the target location and decided to reposition the microcatheter into the posterior branch of the mma.While retracting the third swiftpac back into the microcatheter, the third swiftpac unintentionally detached within the microcatheter.The microcatheter containing the third swiftpac was removed.The procedure was completed using two additional swiftpacs, the same 6f select, the same microcatheter, the same sheath, and the same microwire.There was no report of an adverse effect to the patient.
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, and the pull wire was inside the distal tip of the pusher assembly.If the swiftpac coil is retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire, resulting in the embolization coil detaching from the pusher assembly.Based on the reported complaint, the root cause of resistance could not be determined.Further evaluation revealed kinks in the pusher assembly and offset coil winds along the length of the embolization coil.This damage was incidental to the reported complaint and may have occurred during packaging of the device for return to penumbra.Penumbra coils are 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.

• 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: 20605652
• Report Number: 3005168196-2024-00372
• Device Sequence Number: 20869162
• Product Code: HCG
• UDI-Device Identifier: 00815948029576
• UDI-Public: 00815948029576
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K230284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2024
• 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: F00012368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2024
• 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: 10/10/2024
• Initial Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2024
• 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: 68 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005