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

Model Number M00576670

Device Problems Break (1069); Difficult to Remove (1528); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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) 2016 that an ultraflex tracheobronchial stent was to be used in a bronchoscopy with stent placement procedure performed on (b)(6) 2016.According to the complainant, the stent was placed to treat an 8cm malignant tumor.Reportedly, the patient's anatomy was not tortuous.According to the complainant, during the procedure, the physician was able to deploy the stent.However, the stent was deployed proximal to the tumor.The physician attempted to push the stent down by the stent suture but the stent did not cover the tumor.The physician decided to remove the stent using forceps.During removal, the stent suture started to break apart and the physician had difficulty removing the stent from the trachea.The stent was able to be removed and the physician noted that there were no pieces (from the suture) left in the patient.Another stent was not placed and the physician suggested that the patient undergo radiation to help reduce the size of the tumor.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.

• 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: 5942485
• MDR Text Key: 54414997
• Report Number: 3005099803-2016-02641
• Device Sequence Number: 1
• Product Code: JCT
• 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: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2018
• Device Model Number: M00576670
• Device Lot Number: 19391475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2016
• 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