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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 Leak/Splash (1354); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/26/2020
Event Type  malfunction  
Event Description
It was reported that the balloon ruptured.The 92% stenosed, 10mmx3.5mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 10/3.50 flextome cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured upon first inflation at an atmospheric pressure of 11.3kpa.The device was simply pulled out within the catheter.The procedure was completed with another of the same device.There were no complications reported and patient was stable.
 
Event Description
It was reported that the balloon ruptured.The 92% stenosed, 10mmx3.5mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 10/3.50 flextome cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured upon first inflation at an atmospheric pressure of 11.3kpa.The device was simply pulled out within the catheter.The procedure was completed with another of the same device.There were no complications reported and patient was stable.
 
Manufacturer Narrative
Device evaluated by the 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.The returned device was attached to an encore inflation unit and positive pressure was applied to inflate the balloon.Liquid was observed to be leaking from a balloon pinhole located at the site of the proximal marker band.An examination of the balloon material and proximal markerband identified no issues which could potentially have contributed to this complaint.Blades: a visual and microscopic examination found no issue with the blades.All blades were present and secure in their pads.Tip: no issues were noted with the tip section of the device.Marker bands: a visual and microscopic examination found no issue with the marker bands.Hypotube: a visual and tactile examination found no issue with the hypotube of the device.No other issues were identified during the product 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 Key10695623
MDR Text Key211864548
Report Number2134265-2020-14365
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 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/03/2022
Device Model Number3822
Device Catalogue Number3822
Device Lot Number0024542386
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2020
Date Manufacturer Received11/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age42 YR
Patient Weight73
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