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

Model Number 4677

Device Problems Difficult to Insert (1316); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2024

Event Type  malfunction  

Event Description

It was reported that, during scheduled generator upgrade procedure, this left ventricular (lv) lead was difficult to insert due to tortuous anatomy.The physician took multiple attempts at repositioning this lead, thoroughly washing with heparinized saline each time.A lead catheter had to be used.However, during one attempt, the wire became stuck inside this lead so it could no longer be used.A new lv lead was successfully placed.No additional adverse patient effects were reported outside of the prolonged procedure.As of today, this product has not been received by boston scientific for further analysis.

Event Description

It was reported that, during scheduled generator upgrade procedure, this left ventricular (lv) lead was difficult to insert due to tortuous anatomy.The physician took multiple attempts at repositioning this lead, thoroughly washing with heparinized saline each time.A lead catheter had to be used.However, during one attempt, the wire became stuck inside this lead so it could no longer be used.A new lv lead was successfully placed.No additional adverse patient effects were reported outside of the prolonged procedure.As of today, this product has not been received by boston scientific for further analysis.Later, this product was received by boston scientific and full investigation was conducted.

Manufacturer Narrative

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.A guidewire was returned stuck in the lead, possibly from blood/body fluid in the lumen and the lead is out of shape.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.This is typically due to interaction between the lumen and an inserted stylet or guidewire which is a known inherent risk of the device.

• Brand Name: ACUITY X4 SPIRAL L
• Type of Device: IMPLANTABLE LEAD
• 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: 18777262
• MDR Text Key: 336200586
• Report Number: 2124215-2024-11165
• Device Sequence Number: 1
• Product Code: LWP
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2024
• Device Model Number: 4677
• Device Catalogue Number: 4677
• Device Lot Number: 827146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2022
• 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 Age: 80 YR
• Patient Sex: Female