MAUDE Adverse Event Report: TERUMO SOLOPATH; INTRODUCER, CATHETER

Device Problem Entrapment of Device (1212)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Medtronic received information that after the implant of a transcatheter bioprosthetic valve, a repair was performed on the femoral artery due to the terumo solopath sheath getting caught on the pre close sutures.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SOLOPATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO
• MDR Report Key: 17525211
• MDR Text Key: 321435036
• Report Number: MW5132152
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1