MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II EZ STEROX; IMPLANTABLE LEAD

Model Number 4470

Device Problems Fracture (1260); Use of Device Problem (1670); Defective Device (2588); Contamination /Decontamination Problem (2895)

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

Event Date 01/18/2024

Event Type  Injury  

Event Description

It was reported that this right atrial (ra) lead was explanted due to lead fracture.During the replacement procedure, it was noted that the ra lead insulation was damaged and filled with blood, possibly due to a suture being tied down on the lead instead of the suture sleeve at implant.The ra lead was successfully replaced with a new lead.No additional adverse patient effects were reported.The ra lead is expected to return for analysis.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, visual inspection revealed a cut in the insulation and blood/body fluid in the lumen(s).This type of damage is consistent with induced damage.In this case, we believe the damage occurred during lead implant due to the suture being tied down on the lead and not on a suture sleeve.The reported blood and body fluid in the lead is likely the result of the lead damage observed by the laboratory.

Event Description

It was reported that this right atrial (ra) lead was explanted due to lead fracture.During the replacement procedure, it was noted that the ra lead insulation was damaged and filled with blood, possibly due to a suture being tied down on the lead instead of the suture sleeve at implant.The ra lead was successfully replaced with a new lead.No additional adverse patient effects were reported.The ra lead is expected to return for analysis.

• Brand Name: FINELINE II EZ STEROX
• 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: 18662250
• MDR Text Key: 334799033
• Report Number: 2124215-2024-06991
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00802526264993
• UDI-Public: 00802526264993
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P960004/S014
• 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: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/06/2024
• Device Model Number: 4470
• Device Catalogue Number: 4470
• Device Lot Number: 875536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2022
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male