MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PT2 J-TIP GUIDEWIRE; WIRE, GUIDE, CATHETER

Catalog Number H7493893103J0

Device Problem Entrapment of Device (1212)

Patient Problems Chest Pain (1776); Foreign Body In Patient (2687)

Event Date 06/07/2021

Event Type  Injury  

Event Description

A (b)(6) presenting with chest pain underwent emergent cardiac cath subsequently had unintended retention of pt wire with unsuccessful attempts to snare.Fda safety report id # (b)(4).

• Brand Name: PT2 J-TIP GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 11975224
• MDR Text Key: 255655770
• Report Number: MW5101796
• Device Sequence Number: 1
• Product Code: DQX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2021
• Device Catalogue Number: H7493893103J0
• Device Lot Number: 24408989
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 31 YR
• Patient Weight: 58