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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II EZ STEROX; IMPLANTABLE ELECTRODE
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BOSTON SCIENTIFIC CORPORATION FINELINE II EZ STEROX; IMPLANTABLE ELECTRODE Back to Search Results
Model Number 4471
Device Problems Mechanical Problem (1384); Contamination /Decontamination Problem (2895); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/09/2024
Event Type  malfunction  
Event Description
It was reported that, during implant procedure this right ventricular (rv) lead was an attempt in the left bundle branch (lbb).The physician implanted this rv lead and turned it, when the injury was lost, and the rv lead was pull out.The rv lead got trapped on the tissue, and the physician forced this lead out, leading into a compromised helix.The physician then, unsuccessful attempt to place another rv lead when the cutter slipped and cut the insulation of the rv lead.A new rv lead was implanted.No adverse patient effects were reported.
 
Event Description
It was reported that, during implant procedure this right ventricular (rv) lead was an attempt in the left bundle branch (lbb).The physician implanted this rv lead and turned it, when the injury was lost, and the rv lead was pull out.The rv lead got trapped on the tissue, and the physician forced this lead out, leading into a compromised helix.The physician then, unsuccessful attempt to place another rv lead when the cutter slipped and cut the insulation of the rv lead.A new rv lead was implanted.No adverse patient effects were reported.
 
Manufacturer Narrative
Correction: field h6: code a04 added.
 
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.Measurements throughout this test were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found a deformed helix and a bent stylet.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.Correction: field h6: code a04 added.
 
Event Description
It was reported that, during implant procedure this right ventricular (rv) lead was an attempt in the left bundle branch (lbb).The physician implanted this rv lead and turned it, when the injury was lost, and the rv lead was pull out.The rv lead got trapped on the tissue, and the physician forced this lead out, leading into a compromised helix.The physician then, unsuccessful attempt to place another rv lead when the cutter slipped and cut the insulation of the rv lead.A new rv lead was implanted.No adverse patient effects were reported.
 
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Brand Name
FINELINE II EZ STEROX
Type of Device
IMPLANTABLE ELECTRODE
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 Key18574568
MDR Text Key333633570
Report Number2124215-2024-03714
Device Sequence Number1
Product Code DTB
UDI-Device Identifier00802526265006
UDI-Public00802526265006
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P960004/S014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 03/13/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number4471
Device Catalogue Number4471
Device Lot Number599766
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/11/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age70 YR
Patient SexMale
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