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

Model Number 4671

Device Problem Failure to Capture (1081)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)

Event Date 12/30/2021

Event Type  Injury  

Event Description

It was reported that a left ventricular (lv) lead was attempted to be implanted.The lead was initially implanted appropriately and before hooking the lv lead with the cardiac resynchronization therapy pacemaker (crt-p), the lead dislodged.This second lv lead was attempted implanted.After hooking this second attempted lv lead to the crt-p no capture was obtained and the lead had not moved.It was observed that the catheter moved forward and it was suspected that the catheter and the lv lead went through the vessel.Electrodes were likely outside the vein and this explained the loss of capture.Later, blood pressure dropped and the patient required intensive care unit.Both leads were removed and plugged an lv port for now with possible plan to try an lv lead again the future.The leads have been returned for analysis.No additional adverse patient effects reported.

Manufacturer Narrative

This investigation will be updated should further pertinent information be provided.

Manufacturer Narrative

This investigation will be updated should further pertinent information be provided.Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Testing was completed to assess lead electrical performance and inner insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported that a left ventricular (lv) lead was attempted to be implanted.The lead was initially implanted appropriately and before hooking the lv lead with the cardiac resynchronization therapy pacemaker (crt-p), the lead dislodged.This second lv lead was attempted implanted.After hooking this second attempted lv lead to the crt-p no capture was obtained and the lead had not moved.It was observed that the catheter moved forward and it was suspected that the catheter and the lv lead went through the vessel.Electrodes were likely outside the vein and this explained the loss of capture.Later, blood pressure dropped and the patient required intensive care unit.Both leads were removed and plugged an lv port for now with possible plan to try an lv lead again the future.The leads have been returned for analysis.No additional adverse patient effects reported.

• Brand Name: ACUITY X4 STRAIGHT
• Type of Device: IMPLANTABLE PACEMAKER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 13446252
• MDR Text Key: 285016487
• Report Number: 2124215-2022-03196
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526524516
• UDI-Public: 00802526524516
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P010012/S398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2023
• Device Model Number: 4671
• Device Catalogue Number: 4671
• Device Lot Number: 853206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2021
• Initial Date FDA Received: 02/03/2022
• Supplement Dates Manufacturer Received: 03/23/2022
• Supplement Dates FDA Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2021
• 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): Required Intervention; Hospitalization
• Patient Age: 70 YR