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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

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BOSTON SCIENTIFIC CORPORATION INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER Back to Search Results
Model Number 87047
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Atrial Fibrillation (1729); Unspecified Infection (1930); Thrombosis (2100)
Event Date 11/21/2019
Event Type  Injury  
Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
 
Event Description
(b)(6) clinical study.It was reported that the patient experienced suspected thrombophlebitis with new onset of atrial fibrillation (af).On (b)(6) 2019, during an ablation procedure treat af, the intellanav mifi open-irrigated ablation catheter had a broken sensor, and the catheter not always visible.They exchanged it for a new one.Then on (b)(6) 2019, after the procedure, the patient had an infection with a recurrence of an "at." the devices used during the procedure were two intellanav mifi open-irrigated ablation catheters, an intellamap orion catheter and a zurpaz 8.5 f sheath.The cause was not known.The patient was given an intravenous (iv) medication change on (b)(6) 2019.On (b)(6) 2019, the patient was given amoxicillin.The outcome was unknown.
 
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Brand Name
INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER
Type of Device
CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MN 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
302 parkway, global park
la aurora - heredia
CS  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key9563694
MDR Text Key174724176
Report Number2134265-2019-16582
Device Sequence Number1
Product Code OAD
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 01/08/2020
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
Device Operator Health Professional
Device Expiration Date05/16/2021
Device Model Number87047
Device Catalogue Number87047
Device Lot Number0023811344
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/10/2019
Initial Date FDA Received01/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/17/2019
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age69 YR
Patient Weight97
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