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

Model Number 4469

Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2024

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the right atrial (ra) lead had become dislodged and unable to removed fully as the lead was stuck at the superior vena cava (svc) junction and started to fray.Furthermore, the tip of the lead remained and was cut.Subsequently, the lead was surgically abandoned and replaced with same model.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.Correction to field f10.Patient codes.

Event Description

It was reported that the right atrial (ra) lead had become dislodged and unable to removed fully as the lead was stuck at the superior vena cava (svc) junction and started to fray.Furthermore, the tip of the lead remained and was cut.Subsequently, the lead was surgically abandoned and replaced with same model.No additional adverse patient effects were reported.Additional information received from the field indicating that dislodgement was confirmed with fluoroscopy and testing.

• 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: 18731500
• MDR Text Key: 335702638
• Report Number: 2124215-2024-09684
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00802526265143
• UDI-Public: 00802526265143
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4469
• Device Catalogue Number: 4469
• Device Lot Number: 632058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2023
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Race: White