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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRAFLEX TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE

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BOSTON SCIENTIFIC CORPORATION ULTRAFLEX TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE Back to Search Results
Model Number M00564760
Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/21/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation findings of stent loops bent.A fully deployed ultraflex tracheobronchial covered stent was received for analysis; the delivery system was not returned.Visual inspection was performed and it was found that the loops of the stent were bent.The outer diameter of the stent was measured and was found to be within specification.No other issues with the stent was noted.The reported event of stent partially deployed was not confirmed; the stent was returned completely deployed without the delivery system.Additionally, the loops of the stent were bent; however, there is not sufficient information about what could be the cause for this failure.Taking all available information, there is no indication of what the customer reported because the stent was returned completely deployed.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.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.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/ product label.
 
Event Description
It was reported to boston scientific corporation that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat metastasized thyroid cancer and a malignant stenosis in the left main bronchus during a trans fiberscope stent implantation procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the stent was able to enter into the left main bronchus; however, the stent was unable to fully deploy.Reportedly, the stent was partially deployed on the delivery system when it was removed from the patient.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 stable.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the loops of the stent were bent.Please see for full investigation details.
 
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Brand Name
ULTRAFLEX TRACHEOBRONCHIAL
Type of Device
PROSTHESIS, TRACHEAL, EXPANDABLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key10540304
MDR Text Key207141215
Report Number3005099803-2020-03985
Device Sequence Number1
Product Code JCT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K012883
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial
Report Date 09/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/21/2021
Device Model NumberM00564760
Device Catalogue Number6476
Device Lot Number0023223617
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/26/2020
Initial Date FDA Received09/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/22/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age65 YR
Patient Weight64
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