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

Model Number M00576320

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 01/07/2019

Event Type  Injury  

Manufacturer Narrative

Medwatch report#: mw5083053.Reportedly, the device is available for return but the device has not yet been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2019 that an ultraflex tracheobronchial uncovered distal release stent was implanted during a procedure performed on (b)(6) 2018.According to the complainant, on (b)(6) 2019, during a bronchoscopy procedure, it was noted that the stent had several broken struts along the membranous region about two-thirds (2/3) of the way down.The stent was removed from the patient, exact date unknown.No adverse events were reported as a result of this event.Note: despite numerous attempts, boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event.  should additional relevant details become available, a supplemental report will be submitted.

• 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: 8375977
• MDR Text Key: 137364261
• Report Number: 3005099803-2019-00957
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 08714729837701
• UDI-Public: 08714729837701
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: M00576320
• Device Catalogue Number: 7632
• Device Lot Number: 0022452663
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2018
• 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