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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 3820
Device Problem Material Perforation (2205)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/17/2019
Event Type  malfunction  
Event Description
It was reported that the balloon had a hole.The 80% stenosed target lesion was located in a coronary artery.A 06/3.00 flextome cutting balloon was selected for use.Upon unpacking, a hole was noted on the balloon and could no longer be used.The procedure was completed with another of the same device.No patent complications were reported and the patient's condition was stable.
 
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.Dried inflation media was also observed in both the balloon and lumen.The device was attached to an encore inflation device and positive pressure was applied, however the balloon did not inflate.The device was soaked in the waterbath at 37 degrees celsius to soften the hardened medium or blood that may have been present in the device.The device was removed from the bath and was attached to an encore inflation device and positive pressure was applied and a pinhole leak was identified.The pinhole was 2mm distal of the proximal markerband.An examination of the balloon material and proximal markerband identified no issues which could potentially have contributed to this complaint.All blades were fully bonded onto the balloon.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 found that the hypotube was kinked at multiple locations along its length.This type of damage is consistent with excessive force being applied to the delivery system.No other issues were identified during the product analysis.
 
Event Description
It was reported that the balloon had a hole.The 80% stenosed target lesion was located in a coronary artery.A 06/3.00 flextome cutting balloon was selected for use.Upon unpacking, a hole was noted on the balloon and could no longer be used.The procedure was completed with another of the same device.No patent complications were reported and the patient's condition was stable.
 
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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 Key8771883
MDR Text Key150415994
Report Number2134265-2019-07928
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
PMA/PMN Number
P950020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 08/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/13/2021
Device Model Number3820
Device Catalogue Number3820
Device Lot Number0022510592
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2019
Date Manufacturer Received08/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age73 YR
Patient Weight68
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