MAUDE Adverse Event Report: WALLABY MEDICAL ESPERANCE 3+ ASPIRATION CATHETER SYSTEM; CATHETER, THROMBUS RETRIEVER

Model Number	ASP3F120KIT
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/05/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
As no product has been returned for investigation, we are unable to verify the specific failure mode and thus cannot draw conclusions regarding the root cause.However, a review of manufacturing documentation for lot asp00572 confirmed that the lot was manufactured, inspected, and released in full compliance with all required specifications.No design or labeling modifications that could impact the device's safety have been implemented, and to date, no other complaints or adverse events related to this lot have been reported.No other complaints or adverse events with a similar failure or patient impact have been reported for any other esperance 3f+ product.The device labeling includes appropriate warnings and user instructions for proper operation.Additionally, the risk associated with the reported event is documented in the risk management files, and current control measures are in place to mitigate such risks.Furthermore, the communication with physician indicated that the event was more likely caused by the drive wire "i did not tell you cause it was the drive wire that was the issue.The wire got stuck, it is the second time it has happened to me.It is a problem with the wire.The actuator broke and it damaged and broke the catheter.I then went up and used a stent retriever to pull out the broken tip".
Event or Problem Description
Emergent thrombectomy performed.During the third pass for thrombectomy, part of the esperance aspiration catheter broke off into patient's right middle cerebral artery.The piece was retrieved using a stent retriever; however, significant bleeding was noted.Esperance catheter: manufacturer:wallaby medical lot#: asp00572, ref#: asp3f120kit, exp: 2025.12.06.The wire used with the catheter:drivewire24.Manufacturer: rapid medical lot#: 250301dw01, ref#: drpp2411, exp: 01.31.2026.

• Brand Name: ESPERANCE 3+ ASPIRATION CATHETER SYSTEM
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• 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 new area; shanghai, 20131 5; CH 201315
• Manufacturer Contact: nathaniel knock ; 22901 mill creek drive; laguna hills, CA 92653 ; 9494809466
• MDR Report Key: 22723992
• Report Number: 3014644549-2025-00001
• Device Sequence Number: 12982791
• Product Code: NRY
• UDI-Device Identifier: 06970908213625
• UDI-Public: 06970908213625
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K240917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2025

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 Expiration Date: 12/06/2025
• Device Model Number: ASP3F120KIT
• Device Lot Number: ASP00572
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White