MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-18 GUIDEWIRE; CATHETER, CORONARY, ATHERECTOMY

Patient Problems Hemoptysis (1887); Cardiac Perforation (2513); Thrombosis/Thrombus (4440)

Event Date 02/12/2024

Event Type  Injury  

Event Description

It was reported that one hour post cardiomems implant procedure the patient experienced hemoptysis.The patient was intubated and a bronchoscopy was performed which identified a clot at the site of perforation.The hemoptysis resolved without further intervention.The patient was hospitalized over night.The site did not treat the perforation or clot.The patient is currently fully recovered and has been discharged.The physician reported the likely cause of the perforation was the boston scientific v-18 wire."this report reflects information received by fda in the form of a notification per 803.22 (b)(2)".

• Brand Name: V-18 GUIDEWIRE
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 19194138
• MDR Text Key: 341323719
• Report Number: MW5154364
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2024
• Patient Sequence Number: 1