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

Model Number M00564860

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).An ultraflex tracheobronchial covered distal release stent and delivery system were returned for analysis.Visual examination of the returned device found the stent was received fully deployed off the delivery system and expanded.No other issues were noted to the stent or delivery system.The stent was received deployed and expanded.As there was no issue with the device visual test during product analysis, the complaint incident cannot be confirmed.Based on the analysis performed and the information provided, the most probable root cause for the complaint event is no problem detected since the device complaint or problem cannot be confirmed.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 covered distal release stent was to be used to treat an esophageal and tracheal carcinoma metastases during an airway stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.The complainant initially reported the stent failed to deploy.However, the complainant clarified on may 17, 2019 that during the procedure, the stent was able to be deployed; however, the stent failed to completely expand.The stent was removed with a snare.There were no patient complications as a result of this event.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8680207
• MDR Text Key: 147377840
• Report Number: 3005099803-2019-02953
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K012883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2018
• Device Model Number: M00564860
• Device Catalogue Number: 6486
• Device Lot Number: 0019717120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2019
• Initial Date FDA Received: 06/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 78