MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II STEROX; PERMANENT PACEMAKER ELECTRODE

Model Number	4458
Health Effect - Clinical Codes	Unspecified Infection (1930); Staphylococcus Aureus (2058); Sepsis (2067)
Date of Event	12/09/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report was originally submitted via asr on report id # 1894978 in q1/2015 of the asr report submitted to the fda on #e2011006, which was revoked on 10/02/2017.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.Tanawuttiwat, t., a.Cheng, et al.(2015)."successful extraction of right ventricular lead remnants using the flexcath(r) steerable sheath." j interv card electrophysiol: epub before print.
Event or Problem Description
Manufacturer report id #2124215-2015-00504 corresponds to the initial asr report submitted for exemption #e2011006.Boston scientific received information that this product was part of a system revision due to infection.There were no additional adverse effects reported.The product was explanted.Boston scientific received information in early-january 2016 from a journal article involving a case in which a flexcath steerable sheath, normally used in cryoballoon catheter ablation for atrial fibrillation, was useful in directing a bioptome to a right ventricular lead fragment and thus allowing for complete lead extraction.A (b)(6) year old female with history of diabetes, chronic kidney disease, and sick sinus syndrome underwent dual-chamber pacemaker implantation which included a boston scientific dextrus model#4135 in the right atrium (ra) and fineline ii model#4458 in the right ventricle (rv).In 2014, the patient developed staphylococcus epidermidis sepsis, was found to have a 1.8 cm ra lead vegetation on tee.The patient was referred for system removal.The pulse generator was explanted and the ra lead was easily extracted manually after retraction of the active fixation helix.The rv lead broke during the extraction process, leaving the distal tip in the rv.A curved byrd workstation was exchanged for a 15 french flexcath steerable sheath.Using fluoroscopic guidance in various projections, the physician manipulated the sheath toward the lead fragment.The physician then inserted a bioptome through the gooseneck snare, advanced them together through the sheath, and directed the bioptome toward the rv lead tip which was easily grasped and retracted.Upon removing the bioptome from the flexcath, a long segment of insulation was found which was not evident by fluoroscopy.The radiolucent insulation remnant had presumably prevented the physician from ensnaring the lead tip with the gooseneck snare alone.

• Brand Name: FINELINE II STEROX
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline ave n; st paul,
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado, pr
• Manufacturer Contact: timothy degroot ; 4100 hamline ave n; st paul, mn ; 5826168
• MDR Report Key: 5623164
• Report Number: 2124215-2015-00504
• Device Sequence Number: 3094792
• Product Code: DTB
• UDI-Device Identifier: 00802526060953
• UDI-Public: 00802526060953
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P960004/S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/25/2012
• Device Model Number: 4458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2016
• Supplement Date Received by Manufacturer: 01/06/2016
• Initial Report FDA Received Date: 05/01/2016
• Supplement Report FDA Received Date: 05/01/2016
• Date Device Manufactured: 02/25/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female