MAUDE Adverse Event Report: MEDTRONIC, INC. DXTERITY TRA; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number U5TRAN35SH

Device Problem Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 08/15/2022

Event Type  malfunction  

Event Description

During prep catheter was discovered to be defected.It has an imperfection which didn't allow the wire to go thru the catheter.Catheter has a slight narrowing or bend that didn't allow a wire to pass.Manufacturer response for catheter, medtronic (per site reporter) per report, manufacturer notified.Product handled by site.

• Brand Name: DXTERITY TRA
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 15258052
• MDR Text Key: 298216117
• Report Number: 15258052
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/08/2022,07/28/2022

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
• Device Model Number: U5TRAN35SH
• Device Lot Number: 60327073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1