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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 Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/24/2019
Event Type  malfunction  
Event Description
Reportable based on the additional information received on 29nov2019.The target lesion was located in the left anterior descending artery.A 10/3.50 flextome cutting balloon was selected for use.During the procedure, it was noted that the catheter was broken.The procedure was completed with another of the same device.There were no complications reported and the patient was stable post procedure.
 
Event Description
Reportable based on the additional information received on 29nov2019.The target lesion was located in the left anterior descending artery.A 10/3.50 flextome cutting balloon was selected for use.During the procedure, it was noted that the catheter was broken.The procedure was completed with another of the same device.There were no complications reported and the patient was stable post procedure.
 
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.No tears or holes were visible in the balloon.The device was attached to an encore inflation device and positive pressure was applied.A pinhole leak was located 1mm from the proximal edge 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 with no issues identified.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.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 Key9439018
MDR Text Key175876038
Report Number2134265-2019-15290
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,foreig
Type of Report Initial,Followup
Report Date 02/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/14/2022
Device Model Number3822
Device Catalogue Number3822
Device Lot Number0023645106
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2019
Date Manufacturer Received01/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age77 YR
Patient Weight64
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