MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ULTRAFLEX¿ TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number M00576540

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2018

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the device upn and lot number.Therefore, the manufacture and expiration dates are unknown.It was reported the device was not used past its expiry date.Device code relates to the problem code for the reported event of stent loop wire broke.According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that an ultraflex tracheobronchial covered distal release stent was to be used to treat a stricture due to squamous cell carcinoma of the lung in the left mainstem bronchus during a bronchoscopy with stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not tortuous and was dilated prior to stent placement.According to the complainant, during the procedure, the stent was able to be deployed.However, it appeared that one of the stent loop wires was fractured/broken.The stent was removed from the patient with forceps and the procedure was completed with a different device.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.

• Brand Name: ULTRAFLEX¿ TRACHEOBRONCHIAL
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7321806
• MDR Text Key: 101830796
• Report Number: 3005099803-2018-00542
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 08714729842347
• UDI-Public: 08714729842347
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00576540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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