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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 Problems Inflation Problem (1310); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/30/2019
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery.A 10/3.75 flextome cutting balloon was selected for use.During procedure, upon first inflation, it was noted that the balloon ruptured.The device was simply pulled from the patient's body and the procedure was completed with a different device.There were no patient complications reported and the patient's condition was good.
 
Event Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery.A 10/3.75 flextome cutting balloon was selected for use.During procedure, upon first inflation, it was noted that the balloon ruptured.The device was simply pulled from the patient's body and the procedure was completed with a different device.There were no patient complications reported and the patient's condition was good.It was further reported that the balloon failed to inflate.
 
Manufacturer Narrative
Describe event or problem updated.
 
Event Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery.A 10/3.75 flextome cutting balloon was selected for use.During procedure, upon first inflation, it was noted that the balloon ruptured.The device was simply pulled from the patient's body and the procedure was completed with a different device.There were no patient complications reported and the patient's condition was good.It was further reported that the balloon failed to inflate.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was observed inside the balloon body which is an indication of a balloon leak.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied to inflate the balloon and liquid was observed to be leaking from a balloon pinhole located approximately at the proximal end of the proximal markerband.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 damage or any issues were noted with the blades or tip that could have contributed to the complaint incident.A visual and tactile examination of the shaft of the device identified no kinks or damages.No other issues were identified during device analysis.
 
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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 Key8904476
MDR Text Key154740917
Report Number2134265-2019-09869
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,Followup
Report Date 10/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/12/2020
Device Model Number3822
Device Catalogue Number3822
Device Lot Number0020154873
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2019
Date Manufacturer Received09/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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