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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 Inflation Problem (1310)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/29/2020
Event Type  malfunction  
Event Description
It was reported that the balloon could not apply pressure and failed to inflate.The target lesion area was located in the left anterior descending artery (lad).A 10/2.50 flextome cutting balloon was selected for use in a lad implantation procedure.During the procedure, it was noted that the device could not apply pressure and failed to inflate.A backflow of blood was noted in the balloon.The device was removed from the patient's body.There were no complications reported and the patient is stable.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual inspection identified solidified blood in the balloon.An examination of the balloon identified a longitudinal tear present in the balloon material.The tear measured approximately 1mm in length and was located over the proximal markerband.A microscopic examination of the markerbands identified no issues which could potentially have contributed to the tear.The 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.A visual and tactile examination found no issues present on the device.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the proximal or distal marker bands.34 series of angiographic images taken during the pci procedure and dated 29 october 2020 were provided.A review of the media provided could not identify the alleged inability of the device to be inflated as no unsuccessful attempts of inflation or and leakages/bursts of the predilation balloons were visible throughout this review.It was noted however that one of the predilation balloon was positioned at the lesion site and not inflated but no attempted inflation (contrast noted inside balloon) or any leakages were observed.
 
Event Description
It was reported that the balloon could not apply pressure and failed to inflate.The target lesion area was located in the left anterior descending artery (lad).A 10/2.50 flextome cutting balloon was selected for use in a lad implantation procedure.During the procedure, it was noted that the device could not apply pressure and failed to inflate.A backflow of blood was noted in the balloon.The device was removed from the patient's body.There were no complications reported and the patient is 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 Key10897140
MDR Text Key219186276
Report Number2134265-2020-16286
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,foreig
Type of Report Initial,Followup
Report Date 01/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/08/2023
Device Model Number3822
Device Catalogue Number3822
Device Lot Number0025570745
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2020
Date Manufacturer Received01/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age56 YR
Patient Weight150
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