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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 Problem Material Perforation (2205)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 10/27/2020
Event Type  malfunction  
Event Description
It was reported that a intellanav mifi open-irrigated was used in a three dimensional radiofrequency ablation procedure.It was noted during the procedure a slight fracture occurred between the tip of the device and the shaft.It was also noted that device failed to curve.The procedure was completed using another intellanav with no patient complications being reported.
 
Manufacturer Narrative
Visual examination of the returned complaint device revealed that the main shaft tubing is torn/stretched open near the butt bond.The main shaft was severely bent which caused a tubing fracture adjacent to the proximal edge of the butt bond sleeve.No evidence of fluid ingress at the site of the fracture and the butt bond seal appears intact.Dried body fluid found on the main shaft.Dried saline found in luer and on the distal end.There is no evidence this device was used in a manner inconsistent with the labeled indications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
Event Description
It was reported that a intellanav mifi open-irrigated was used in a three dimensional radiofrequency ablation procedure.It was noted during the procedure a slight fracture occurred between the tip of the device and the shaft.It was also noted that device failed to curve.The procedure was completed using another intellanav with no patient complications being reported.
 
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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
MDR Report Key10895907
MDR Text Key218940261
Report Number2134265-2020-16348
Device Sequence Number1
Product Code OAD
UDI-Device Identifier08714729938361
UDI-Public08714729938361
Combination Product (y/n)N
PMA/PMN Number
P150005/S017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/12/2021
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 Expiration Date12/16/2021
Device Model Number87047
Device Catalogue Number87047
Device Lot Number0024945847
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2020
Initial Date Manufacturer Received 10/29/2020
Initial Date FDA Received11/24/2020
Supplement Dates Manufacturer Received12/21/2020
Supplement Dates FDA Received01/12/2021
Patient Sequence Number1
Patient Age53 YR
Patient Weight75
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