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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXTOME CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION FLEXTOME CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 3822
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/08/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a balloon rupture occurred.A 10/3.50 flextome cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at 10atm.The device was simply removed from the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient was good post procedure.
 
Manufacturer Narrative
Initial reporter city: (b)(6).Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.The balloon could not be inflated due to the presence of solidified blood that was present within the inflation lumen.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the blood before further inflation attempts were made.The device was removed from the bath and the balloon was again attached to an inflation device subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole located approximately 4mm proximal of the distal markerband.An examination of the balloon material and distal markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination identified no kinks or damage to the shaft or hypotube of the returned device.No other issues were identified during the product analysis.
 
Event Description
It was reported that a balloon rupture occurred.A 10/3.50 flextome cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at 10atm.The device was simply removed from the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient was good post procedure.
 
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Brand Name
FLEXTOME CUTTING BALLOON
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9359944
MDR Text Key173508143
Report Number2134265-2019-14319
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 12/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/25/2021
Device Model Number3822
Device Catalogue Number3822
Device Lot Number0021663407
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2019
Date Manufacturer Received12/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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