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

Model Number 4671

Device Problems Use of Device Problem (1670); Defective Device (2588); Device Dislodged or Dislocated (2923)

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

Event Date 02/04/2022

Event Type  malfunction  

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis, should further pertinent information be provided.

Event Description

It was reported that this left ventricular (lv) lead was not successfully implanted due to insulation damage.According to the information provided, when the physician tried cutting the accessory guidewire, the cutter slipped off and at the time of cutting the distal tip of the guidewire, the lv lead dislodged.The physician regained access with a new guidewire but upon inspecting the lead before implanting it, blood and air bubbles were noted within the lumen and insulation of the lead.Consequently, the product was not used and a non boston scientific lead was implanted to complete the procedure.The physician believes he clipped the lead insulation while using the scissors to cut the guidewire.No adverse patient effects were reported.The product was received for analysis.

Event Description

It was reported that this left ventricular (lv) lead was not successfully implanted due to insulation damage.According to the information provided, when the physician tried cutting the accessory guidewire, the cutter slipped off and at the time of cutting the distal tip of the guidewire, the lv lead dislodged.The physician regained access with a new guidewire but upon inspecting the lead before implanting it, blood and air bubbles were noted within the lumen and insulation of the lead.Consequently, the product was not used and a non boston scientific lead was implanted to complete the procedure.The physician believes he clipped the lead insulation while using the scissors to cut the guidewire.No adverse patient effects were reported.The product was received for analysis.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Visual inspection found dried blood in the tip region of the lead and no insulation damage was found.Testing was completed to assess lead electrical performance and inner/outer insulation integrity.Measurements throughout these tests were within normal limits.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 dislodgement.

• 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 (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: 14023726
• MDR Text Key: 288688699
• Report Number: 2124215-2022-06005
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2023
• Device Model Number: 4671
• Device Catalogue Number: 4671
• Device Lot Number: 852393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2021
• 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 Age: 74 YR
• Patient Sex: Male