MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY X4 STRAIGHT; IMPLANTABLE LEAD

Model Number 4672

Device Problems Failure to Capture (1081); Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problems Chest Pain (1776); Pleural Effusion (2010); Cardiac Tamponade (2226); Cardiac Perforation (2513); Vascular Dissection (3160)

Event Date 02/28/2024

Event Type  Injury  

Event Description

It was reported that a cardiac tamponade occurred during the attempted left ventricular (lv) lead implant.Lv lead was attempted to be placed several times, however due to the patient's vasculature, the lead was unable to be successfully placed in the target vein, and loss of capture was noted.A dissection was suspected and confirmed by venogram, with contrast in the myocardium and pericardial space.The physician persisted in placing the lv lead, when increased contrast was noted in the pericardial space via x-ray, and the patient began to report chest pain.Subsequently, an echocardiogram was performed, and a pericardial effusion was observed.The physician decided to abort the lv lead placement, and a pericardiocentesis was performed.The cardiac resynchronization therapy pacemaker (crt-p) was successfully programmed with right atrial (ra) lead and right ventricular (rv) leads, and the patient is stable an expected to make a full recovery.No additional adverse patient effects were reported.

• Brand Name: ACUITY X4 STRAIGHT
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18837092
• MDR Text Key: 336894205
• Report Number: 2124215-2024-13337
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: P010012/S398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4672
• Device Catalogue Number: 4672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention