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

Model Number M00564750

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).A deployed ultraflex tracheobronchial covered stent was received for analysis; the delivery system was not returned.Visual examination found the stent was expanded.No issues were noted to the stent.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 on may 20, 2019 that an ultraflex tracheobronchial covered distal release stent was implanted to treat a stenosis in the left main bronchus during a stenting procedure performed on (b)(6) 2019.According to the complainant, on (b)(6) 2019, the stent was noted as not fully expanded even 48 hours after the stent placement.The stent was removed from the patient with forceps.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be fine.

• 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: 8704216
• MDR Text Key: 148177358
• Report Number: 3005099803-2019-02969
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/17/2019

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: 08/21/2019
• Device Model Number: M00564750
• Device Catalogue Number: 6475
• Device Lot Number: 0021032330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 06/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2017
• 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