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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV MIFI OPEN-IRRIGATED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
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BOSTON SCIENTIFIC CORPORATION INTELLANAV MIFI OPEN-IRRIGATED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER Back to Search Results
Model Number 87047
Device Problems Crack (1135); Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/12/2023
Event Type  malfunction  
Event Description
The intellanav mifi oi catheter was selected for use during the procedure to treat atrial fibrillation (a fib).The catheter was placed into the la via transeptal.It was reported that magnetic tracking issues and loss of catheter occurred when the left inferior pulmonary vein (lipv) was performed.This issue occurred multiple times intermittently.Noise was only present on the catheter bipoles.It was also noted that temperature limited further ablation with the catheter at 52 degrees read inside the blood pool.The catheter was removed and inspected.It was observed that the handle was separating.The device was replaced with a new one from the same model.The procedure was completed successfully.No patient complications were reported.The device is not available for return.
 
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.
 
Manufacturer Narrative
It was indicated that the device will not be returned for evaluation, however, inspection of media provided confirmed that crack was observed on the handle of the device.Nevertheless, since the device was not returned by the costumer the cause of the reported device no signal, noisy electrogram and temperature cath-poor temperature control complaint event could not be established.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.There is no evidence that the device was used in a manner inconsistent with the labelled indications/ifu.
 
Event Description
The intellanav mifi oi catheter was selected for use during the procedure to treat atrial fibrillation (a fib).The catheter was placed into the la via transeptal.It was reported that magnetic tracking issues and loss of catheter occurred when the left inferior pulmonary vein (lipv) was performed.This issue occurred multiple times intermittently.Noise was only present on the catheter bipoles.It was also noted that temperature limited further ablation with the catheter at 52 degrees read inside the blood pool.The catheter was removed and inspected.It was observed that the handle was separating.The device was replaced with a new one from the same model.The procedure was completed successfully.No patient complications were reported.The device is not available for return.
 
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Brand Name
INTELLANAV MIFI OPEN-IRRIGATED
Type of Device
CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 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 Key17287197
MDR Text Key318688816
Report Number2124215-2023-34202
Device Sequence Number1
Product Code OAD
UDI-Device Identifier08714729938361
UDI-Public08714729938361
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P150005/S017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number87047
Device Catalogue Number87047
Device Lot Number0030919613
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/12/2023
Initial Date FDA Received07/10/2023
Supplement Dates Manufacturer Received07/05/2023
Supplement Dates FDA Received07/19/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/25/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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