MAUDE Adverse Event Report: REFLOW MEDICAL, INC. SPEX18; CATHETER, PERCUTANEOUS

Model Number	SPX18150US
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient presents for a left leg artery peripheral intervention.During attempts to cross the occluded left superficial artery the radiopaque tip from a catheter call the spex 18 sheared off.

• Brand Name: SPEX18
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): REFLOW MEDICAL, INC.; 208 avenida fabricante suite 100; san clemente CA 92672
• MDR Report Key: 11892946
• Report Number: 11892946
• Device Sequence Number: 11689943
• Product Code: DQY
• UDI-Device Identifier: 00856492005340
• UDI-Public: (01)00856492005340
• 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): 05/12/2021
• Report Date (Section F): 05/12/2021

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: SPX18150US
• Device Catalogue Number: SPX18150US
• Device Lot Number: 1906061
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2021
• Patient Sequence Number: 1
• Date Report Sent to FDA: 05/12/2021