MAUDE Adverse Event Report: DXTERITY¿ TRA; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	U5TRACTSHA
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of atrial fibrillation, hypertension and heart failure.With new onset chest pain, to heart cath lab for diagnostic heart cath.When prepping the cath, the j-wire would not go through the catheter.Product was not used on patient, new device obtained.

• Brand Name: DXTERITY¿ TRA
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11331806
• Report Number: 11331806
• Device Sequence Number: 2590266
• Product Code: DQO
• UDI-Device Identifier: 00643169739130
• UDI-Public: (01)00643169739130(17)230824(10)60253683
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/10/2021
• Report Date (Section F): 02/10/2021

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: U5TRACTSHA
• Device Lot Number: 60253683
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/16/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2021
• 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 Weight: 134
• Date Report Sent to FDA: 02/10/2021