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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 Problem No Consequences Or Impact To Patient (2199)
Event Date 03/28/2019
Event Type  malfunction  
Event Description
It was reported that catheter break occurred.A nav mifi oi was selected for a right atrial flutter ablation procedure.During mapping the physician pulled the catheter out to re-position it and when he went to put it back in it was noticed that the plastic on catheter was broken.The second catheter had a bad hdr error as the tip that was bad.The procedure was completed using another catheter and no patient complications occurred.
 
Event Description
It was reported that catheter break occurred.A nav mifi oi was selected for a right atrial flutter ablation procedure.During mapping the physician pulled the catheter out to re-position it and when he went to put it back in it was noticed that the plastic on catheter was broken.The second catheter had a bad hdr error as the tip that was bad.The procedure was completed using another catheter and no patient complications occurred.
 
Manufacturer Narrative
Visual inspection showed that the main shaft was severely bent which caused a tubing fracture open immediately proximal from the butt bond.A closer inspection found the tear/fracture aligns with 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 handle, main shaft, and distal end.
 
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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
4100 hamline avenue north
saint paul MN 55112
MDR Report Key8544289
MDR Text Key142908736
Report Number2134265-2019-04271
Device Sequence Number1
Product Code OAD
UDI-Device Identifier08714729938361
UDI-Public08714729938361
Combination Product (y/n)N
PMA/PMN Number
P150005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/09/2020
Device Model Number87047
Device Catalogue Number87047
Device Lot Number0023061692
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2019
Date Manufacturer Received05/31/2019
Patient Sequence Number1
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