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

Model Number	10CFR15030
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturing document review of the wallaby avenir coil system lot wcs02526 was performed.After reviewing the documents, the lot wcs02526 was manufactured, inspected, and released to all required specifications.No non-conformance was issued or reported for this lot.Lot wcs02526 was not involved in any other complaint or event.The device was not returned to the manufacturer for analysis; therefore, the product issue cannot be verified.The investigation and report of this event was completed prior to reporting requirement of 21cfr 803.50,however submission was delayed during the account creation process.This is the first electronic report for wallaby medical.During the account creation process, the first test report was sent on (b)(6) 2024 and failure notice of ak2 was received shortly after.Since ak2 failed, the submission process was reviewed and a new test report was submitted on (b)(6) 2024.In addition to the internal review, a help request was sent to the esg help desk, for support, on (b)(6) 2024 (ticket (b)(4)).The company reached out to the cdrh emdr and emdr policy groups for support.Full details of this assessment are maintained by wallaby medical.
Event or Problem Description
A headway 167 duo was navigated under high tortuosity, physician attempted to deploy a avenir coil((b)(6)).There was high flow, causing it to be quite turbulent.As the coil was deployed, flow would catch the coil and cause it to compact into one corner of the fistula cavity.As the physician continued to push coil out, it would continue to become compressed into one corner of the fistula.The physician then proceeded to retrieve the coil.After retrieving/ pushing coil out a few times, the coil become "bunched" up on itself, and the coil stretched upon final retrieving/retract.The physician required the use stent retriever to pull back the stretched coil.There was on patient harm reported in this event.

• Brand Name: WALLABY AVENIR COIL SYSTEM
• Common Device Name: NEUROVASCULAR EMBOLIZATION COIL
• Manufacturer (Section D): WALLABY MEDICAL; 22901 mill creek drive; laguna hills CA 92653
• Manufacturer (Section G): SHANGHAI WALLABY MEDICAL TECHNOLOGIES CO., INC.; area c, no.3; lane 299, kangwei road, pudong; shanghai, ; CH
• Manufacturer Contact: nathaniel knock ; 22901 mill creek drive; laguna hills 92653 ; 9494809466
• MDR Report Key: 19356502
• Report Number: 3014644549-2024-00001
• Device Sequence Number: 12354311
• Product Code: HCG
• UDI-Device Identifier: 06970908211355
• UDI-Public: 06970908211355
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 05/21/2024

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: 10CFR15030
• Device Lot Number: WCS02526
• 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: 04/18/2024
• Initial Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2022
• 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 Age: 3 MO
• Patient Sex: Prefer Not To Disclose