MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. RIST 079; CATHETER, PERCUTANEOUS

Model Number	107F-079-95
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Radial access guide catheter would not advance in brachial artery.Upon removal, the cath started to unwind and tip broke off.X-ray images confirmed tip in vessel.Upon completion of neuro intervention, the patient was taken to the or (operating room) for successful retrieval of catheter by vascular surgeon.

• Brand Name: RIST 079
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICRO THERAPEUTICS, INC.; 5290 california avenue; irvine CA 92617
• MDR Report Key: 19749744
• Report Number: 19749744
• Device Sequence Number: 15739516
• Product Code: DQY
• UDI-Device Identifier: 00763000413767
• UDI-Public: (01)00763000413767
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/18/2024
• Report Date (Section F): 06/18/2024

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 Model Number: 107F-079-95
• Device Lot Number: 23945-1004042027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 07/16/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: White
• Date Report Sent to FDA: 06/18/2024