Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXTOME CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION FLEXTOME CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 3822
Device Problem Material Rupture (1546)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/17/2020
Event Type  malfunction  
Event Description
It was reported that the balloon burst.The target lesion was located in the left anterior descending artery.A 10/2.50 flextome cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured upon first inflation near working pressure for a few seconds.The device was simply pulled out from the patient's body.The procedure was completed with a different device.No complications reported and patient was stable.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual and microscopic examination of the balloon found the wings to be in a deflated state and had been subjected to positive pressure.Blood was identified within the balloon 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 balloon could not be inflated due to solidified media that was present within the inflation lumen.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the media before further inflation attempts were made.The device was removed from the bath and the balloon was again attached to an inflation device, subjected to positive pressure, and liquid was observed to be leaking from a balloon pinhole located approximately 3 mm proximal to the distal marker band.The balloon material, blades and markerbands 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.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 marker bands.
 
Event Description
It was reported that the balloon burst.The target lesion was located in the left anterior descending artery.A 10/2.50 flextome cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured upon first inflation near working pressure for a few seconds.The device was simply pulled out from the patient's body.The procedure was completed with a different device.No complications reported and patient was stable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11131854
MDR Text Key225526995
Report Number2134265-2020-18828
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 03/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/15/2023
Device Model Number3822
Device Catalogue Number3822
Device Lot Number0025595935
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2021
Date Manufacturer Received02/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age40 YR
Patient Weight70
-
-