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

Model Number M00564520

Device Problems Difficult to Remove (1528); Positioning Problem (3009); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/04/2018

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) 2018 that an ultraflex tracheobronchial uncovered distal release stent was to be used during a stent placement procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the stent was able to be deployed inside the patient, however, the delivery system was unable to be removed.It was noted that the proximal end of the stent was on the delivery system and was not fully expanded.Reportedly, the delivery system could not be removed without pulling the stent out from the patient; the stent was moved back and forth during withdrawal of the device.The stent and delivery system were successfully removed, 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 stable.

• Brand Name: ULTRAFLEX¿ TRACHEOBRONCHIAL
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7722665
• MDR Text Key: 115111160
• Report Number: 3005099803-2018-02387
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• 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: 07/04/2018

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: 05/13/2020
• Device Model Number: M00564520
• Device Catalogue Number: 6452
• Device Lot Number: 22113819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2018
• Initial Date FDA Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2018
• 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