MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-18 CONTROL WIRE; WIRE, GUIDE, CATHETER

Model Number 40495

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Pain (1994); Perforation (2001); Pericardial Effusion (3271)

Event Date 09/19/2021

Event Type  Injury  

Event Description

It was reported that vessel perforation, pericardial effusion, hypotension, chest pain, and back pain occurred.A 300cm, 8cm poly tip v-18 control wire was used in a cardiomems implant procedure.Following the procedure, the patient began complaining of back pain and chest pain, and blood pressure began to drop.It was found that the right ventricle had been perforated and the patient had pericardial effusion.A computerized tomography (ct) scan and echocardiogram were performed, and the pericardial effusion was identified.A pericardiocentesis procedure was performed to drain the effusion.The patient was brought to intensive care unit for monitoring but remained unstable.Subsequently, the patient was sent to open heart surgery to assess and repair the source of pericardial effusion.The physician successfully repaired the perforation in the right ventricle and the patient is recovering.

• Brand Name: V-18 CONTROL WIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15715432
• MDR Text Key: 302858538
• Report Number: 2124215-2022-41785
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08714729070207
• UDI-Public: 08714729070207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2023
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0027363757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other