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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 3824
Device Problems Material Rupture (1546); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/20/2019
Event Type  malfunction  
Event Description
It was reported that the balloon leaked.The target lesion was located in the right coronary artery.A 15/3.00 flextome cutting balloon was selected for use.During the procedure, it was noted that the balloon could not cross the lesion and the contrast was leaking.The balloon was then removed without any intervention.The procedure was completed with another of the same device.No complications reported and patient was stable.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified blood inside the balloon which is evidence of a device leak.A visual and microscopic examination of the balloon material identified no issues which could potentially have contributed to this complaint.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied but the balloon could not be inflated due to a shaft leak.The markerbands and tip section of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.A visual and tactile examination identified that the shaft polymer extrusion was damaged at the guidewire port.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied, and liquid was observed to be exiting from a shaft leak located at the guidewire port.This type of damage is consistent with excessive force being applied to the delivery system and the shaft being pushed against the guidewire causing an abrasion.A visual and tactile examination identified that the hypotube was kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.No other issues were identified during the product analysis.
 
Event Description
It was reported that the balloon leaked.The target lesion was located in the right coronary artery.A 15/3.00 flextome cutting balloon was selected for use.During the procedure, it was noted that the balloon could not cross the lesion and the contrast was leaking.The balloon was then removed without any intervention.The procedure was completed with another of the same device.No complications reported and patient 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 Key9435068
MDR Text Key175699964
Report Number2134265-2019-15231
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 02/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3824
Device Catalogue Number3824
Device Lot Number0023759639
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2019
Date Manufacturer Received01/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age62 YR
Patient Weight75
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