MAUDE Adverse Event Report: WALLABY MEDICAL WALLABY AVENIR COIL SYSTEM; NEUROVASCULAR EMBOLIZATION COIL

Model Number	10CSW02020
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After reviewing the manufacturing documents, the lot wcs10086 was manufactured, inspected, and released to all required specifications.And this lot was not involved in any other complaint or event.Based on the visual evaluation we can confirm that the coil was abnormally detached from pusher, leaving the inner components still attached to the pull wire, and several kinks were observed in pusher.But since the coil and the ancillary devices were not returned for evaluation we couldn't confirm the root cause.
Event or Problem Description
Procedure was an mma embolization.Coil was the last one in.Coil was partially in place when the benchmark fell down dragging the coil in to the internal carotid artery.Coil retrievel was attempted, but stretched in the process causing filament to be in the ica.Scepter balloon was used to push filament back into eca.Filament was later surgically removed.
Additional Manufacturer Narrative
Since the device remains under investigation and certain information was unavailable for the initial report, a follow-up report will be submitted as appropriate.
Event or Problem Description
Procedure was an mma embolization.Coil was the last one in.Coil was partially in place when the benchmark fell down dragging the coil in to the internal carotid artery.Coil retrievel was attempted but stretched in the process causing filament to be in the ica.Scepter balloon was used to push filament back into eca.Filament was later surgically removed.

• Brand Name: WALLABY AVENIR COIL SYSTEM
• Common Device Name: NEUROVASCULAR EMBOLIZATION COIL
• Manufacturer (Section D): WALLABY MEDICAL; 22901 mill creek drive; laguna hills 92653
• Manufacturer (Section G): SHANGHAI WALLABY MEDICAL TECHNOLOGIES CO., INC.; lane 299, kangwei road, pudong; area c, no.3; shanghai, 20131 5; CH 201315
• Manufacturer Contact: nate nathaniel ; 22901 mill creek drive; laguna hills 92653 ; 9494809466
• MDR Report Key: 23825734
• Report Number: 3014644549-2025-00002
• Device Sequence Number: 12010122
• Product Code: HCG
• UDI-Device Identifier: 06970908212840
• UDI-Public: 06970908212840
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 10CSW02020
• Device Lot Number: WCS10086
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2025
• 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: Unknown