MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPO¿; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number H74908641211

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 08/10/2021

Event Type  malfunction  

Event Description

Expo¿ angiographic catheter kinked inside the subclavian artery via radial access.Groin access was obtained and catheter was successfully removed.

• Brand Name: EXPO¿
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12561201
• MDR Text Key: 274268096
• Report Number: 12561201
• 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
• Type of Report: Initial
• Report Date: 09/21/2021

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
• Device Operator: No Information
• Device Model Number: H74908641211
• Device Catalogue Number: H74908641211
• Device Lot Number: 60296041
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2021
• Date Report to Manufacturer: 10/01/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18250 DA