MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. RISTTM; CATHETER, PERCUTANEOUS, NEUROVASCULATURE

Model Number	106F-071-100
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
After radial access obtained, attempted to advance rist catheter into radial artery.Difficulty noted in advancing catheter, which was in an accessory radial artery.Attempted to withdraw catheter, at which time a distal fragment of the catheter broke off and was lodged in the accessory radial artery.Decision was made it would be more dangerous to attempt to retrieve the fragment (with risk of vessel rupture) rather to keep fragment in place.Successfully used benchmark guide catheter to finish treating aneurysm.Patient awoke with no new deficits or complications.

• Brand Name: RISTTM
• Common Device Name: CATHETER, PERCUTANEOUS, NEUROVASCULATURE
• Manufacturer (Section D): MICRO THERAPEUTICS, INC.; 9775 toledo way; irvine CA 92618
• MDR Report Key: 15191643
• Report Number: 15191643
• Device Sequence Number: 14946685
• Product Code: QJP
• UDI-Device Identifier: 00763000541200
• UDI-Public: (01)00763000541200
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 07/20/2022
• Report Date (Section F): 07/20/2022

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: 106F-071-100
• Device Lot Number: 19139-01
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2022
• 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
• Patient Sex: Female
• Patient Weight: 53 KG
• Date Report Sent to FDA: 07/20/2022