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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 Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/19/2020
Event Type  malfunction  
Event Description
It was reported that balloon was difficult to withdraw.The 8mm, 70% stenosed target lesion area was located in the middle left anterior descending artery.A 06/3.50 flextome cutting balloon was selected for use in a percutaneous coronary intervention.During the procedure, it was noted that after cutting, the device was difficult to withdraw and finally removed within the guiding catheter all together.The device was completely removed from the patient's body.The procedure was completed with another of the same device.There were no further complications reported and the patient is stable.
 
Event Description
It was reported that balloon was difficult to withdraw.The 8mm, 70% stenosed target lesion area was located in the middle left anterior descending artery.A 06/3.50 flextome cutting balloon was selected for use in a percutaneous coronary intervention.During the procedure, it was noted that after cutting, the device was difficult to withdraw and finally removed within the guiding catheter all together.The device was completely removed from the patient's body.The procedure was completed with another of the same device.There were no further complications reported and the patient is stable.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual and microscopic examination of the balloon folds found the wings to be in a deflated state and had been subjected to positive pressure.The balloon and blades of the device were visually and microscopically examined, and no issues were noted that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon surface.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.A visual and tactile examination found a complete break on the shaft polymer extrusion at approx.135 cm distal from the strain relief.
 
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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 Key10734119
MDR Text Key213038227
Report Number2134265-2020-14645
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 12/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/02/2022
Device Model Number3820
Device Catalogue Number3820
Device Lot Number0023737457
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2020
Date Manufacturer Received11/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age65 YR
Patient Weight61
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