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 ULTRAFLEX TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE
  • 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 ULTRAFLEX TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE Back to Search Results
Model Number M00564590
Device Problems Break (1069); Unraveled Material (1664); Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/02/2019
Event Type  malfunction  
Manufacturer Narrative
Health care facility name: (b)(6).(b)(4).An ultraflex tracheobronchial covered distal release stent was returned for analysis; the delivery system was not returned.Visual examination of the returned device found the stent was received deployed, unraveled and expanded.One green retention suture was present and broken.The other green retention suture was present and no anomalies was noted.No other issue with the stent was noted.The damages noted of the returned device may have been a result of manipulation, excessive handling or resistance encountered during the procedure.Taking all available information into consideration, the investigation concluded that the observed failures may be related to procedural factors such as handling of the device, the technique used by the user, and normal procedural difficulties encountered during the procedure, which limited the performance of the device.Therefore, the most probable root cause is adverse event related to the procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.
 
Event Description
It was reported to boston scientific corporation that an ultraflex tracheobronchial uncovered distal release stent was to be used in the trachea to treat an airway stenosis during a stenting procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was dilated prior to stent placement.According to the complainant, during the procedure, the tip of the stent was able to be deployed but could not be released further.The physician attempted to pull out the stent directly, but ended up removing the stent partially deployed on the delivery system with the rigid endoscope.The procedure was completed with another ultraflex tracheobronchial stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.Note: this event has been deemed a mdr-reportable event based on investigation results which revealed that the stent was unraveled and one retention suture was broken.
 
Manufacturer Narrative
Block b5 has been updated with additional information received on february 06, 2020.Block e1: health care facility name: (b)(6).Block h6: problem code 1069 captures the reportable investigation finding of retention suture broken.Problem code 1664 captures the reportable investigation finding of stent suture unraveled.Block h10: an ultraflex tracheobronchial covered distal release stent was returned for analysis; the delivery system was not returned.Visual examination of the returned device found the stent was received deployed, unraveled and expanded.One green retention suture was present and broken.The other green retention suture was present and no anomalies was noted.No other issue with the stent was noted.The damages noted of the returned device may have been a result of manipulation, excessive handling or resistance encountered during the procedure.Taking all available information into consideration, the investigation concluded that the observed failures may be related to procedural factors such as handling of the device, the technique used by the user, and normal procedural difficulties encountered during the procedure, which limited the performance of the device.Therefore, the most probable root cause is adverse event related to the procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.
 
Event Description
It was reported to boston scientific corporation that an ultraflex tracheobronchial uncovered distal release stent was to be used in the trachea to treat an airway stenosis during a stenting procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was dilated prior to stent placement.According to the complainant, during the procedure, the tip of the stent was able to be deployed but could not be released further.The physician attempted to pull out the stent directly, but ended up removing the stent partially deployed on the delivery system with the rigid endoscope.The procedure was completed with another ultraflex tracheobronchial stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.Note: this event has been deemed a mdr-reportable event based on investigation results which revealed that the stent was unraveled and one retention suture was broken.Please see block h10 for full investigation details.Additional information received on (b)(6) 2020: on (b)(6) 2020, it was reported that during stent deployment, the ultraflex tracheobroncial stent became unraveled inside the patient.The physician attempted to remove the stent without using any tools but it failed to remove the stent.A rigid endoscope was then used and the stent was successfully removed.Reportedly, the stent was able to be deployed outside the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ULTRAFLEX TRACHEOBRONCHIAL
Type of Device
PROSTHESIS, TRACHEAL, EXPANDABLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9678053
MDR Text Key190114514
Report Number3005099803-2020-00346
Device Sequence Number1
Product Code JCT
Combination Product (y/n)N
PMA/PMN Number
K012883
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/04/2020
Device Model NumberM00564590
Device Catalogue Number6459
Device Lot Number0021565681
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2019
Date Manufacturer Received02/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age62 YR
Patient Weight91
-
-