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

Model Number M00576610

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2020

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2020 that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat a malignant neoplasm in the distal trachea during a tracheobronchial airway stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was slightly tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was deployed and the delivery system was successfully removed from the patient.Reportedly, the physician introduced the bronchoscope to check for stent placement and it was noted that the distal portion of the stent did not fully expand; the nitinol loops bent inwards.The physician attempted to adjust the stent by pulling the stent both proximally and distally with rat-toothed grasping forceps, but the stent did not fully expand at the distal end.The stent was removed with rat- toothed forceps and a different stent was placed to complete the procedure.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 and 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10171187
• MDR Text Key: 195808606
• Report Number: 3005099803-2020-02375
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 08714729842415
• UDI-Public: 08714729842415
• 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: 06/18/2020

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: 01/20/2022
• Device Model Number: M00576610
• Device Catalogue Number: 7661
• Device Lot Number: 0025074167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2020
• 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