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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY FLEXTOME¿ CUTTING BALLOON¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC - GALWAY FLEXTOME¿ CUTTING BALLOON¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H749RB4200100
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/08/2017
Event Type  malfunction  
Manufacturer Narrative
Age at time of event:18 years or older.(b)(4).
 
Event Description
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified coronary artery.A 10/2.00 flextome® cutting balloon® was selected for use.During procedure, it was noted that the balloon catheter was unable to cross the lesion.When the balloon was inflated in the lesion area, the balloon ruptured below the nominal pressure.The procedure was completed with a different device.No patient complications were reported and the patient's condition was good.
 
Manufacturer Narrative
Device evaluated by mfr: device was returned for analysis.The tip section of the device was visually and microscopically examined and no issues were noted that could have potentially contributed to the complaint incident.A visual and microscopic examination identified no issues with the blades.All blades were present and fully bonded to the balloon material.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and lumen which is evidence of a device leak.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.The device was subjected to positive pressure and liquid was observed to be leaking from a longitudinal tear on the balloon material starting approximately at the distal edge of the distal markerband and extending approximately 5mm proximally.An examination of the balloon material identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination found no issues with the markerbands of the device that could have contributed to the complaint event.A visual and tactile examination of the device identified no issues with the shaft of the device that could have contributed to the complaint event.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
 
Event Description
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified coronary artery.A 10/2.00 flextome® cutting balloon® was selected for use.During procedure, it was noted that the balloon catheter was unable to cross the lesion.When the balloon was inflated in the lesion area, the balloon ruptured below the nominal pressure.The procedure was completed with a different device.No patient complications were reported and the patient's condition was good.
 
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Brand Name
FLEXTOME¿ CUTTING BALLOON¿
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7135720
MDR Text Key95669153
Report Number2134265-2017-12691
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
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/25/2020
Device Model NumberH749RB4200100
Device Catalogue NumberRB420010
Device Lot Number0020813603
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/08/2017
Initial Date FDA Received12/20/2017
Supplement Dates Manufacturer Received01/09/2018
Supplement Dates FDA Received01/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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