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

Lot Number 60288016

Device Problems Difficult to Remove (1528); Material Deformation (2976)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/25/2022

Event Type  Injury  

Event Description

A 6f pinnacle sheath was placed in the patient's right femoral artery and the physician was trying to insert the boston scientific 5f expo williams catheter in the sheath.The physician was having issues with the engaging the artery and was having to twist to get the catheter engaged.When they panned out to look at the arteries the catheter was kinked right outside the sheath and inside the artery.When the physician tried to pull the catheter out it wouldn't come out.He didn't want to cause harm to patient so he left in and consulted a cv surgeon.The cv surgeon was able to remove in the operating room.Route: intra-arterial.Diagnosis for use: stemi.Fda safety report id# (b)(4).

• Brand Name: BOSTON SCIENTIC CATHETER EXPO WILLIAMS
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 15138219
• MDR Text Key: 297065475
• Report Number: MW5111200
• 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: No Information
• Type of Report: Initial
• Report Date: 07/28/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 60288016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Race: White