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

Model Number M00564770

Device Problems Material Separation (1562); Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an ultraflex tracheobronchial covered distal release stent was to be implanted in the bronchus to treat a bronchial stenosis during a procedure performed on (b)(6) 2023.The patient's anatomy was dilated prior to stent placement.During the procedure, the stent did not fully release from the delivery system due to patient's bronchial stenosis being too narrow.The stent was removed from the patient partially deployed on the delivery system.However, it was noticed that after withdrawal of the delivery system, the silicone sleeve at the anterior end of the delivery system has fallen into the patient's bronchus.The fallen part was clamped out with foreign body forceps.The procedure was not completed, and no new stent was implanted in the patient.The patient was subsequently treated conservatively, and there were no abnormalities to the patient.The patient's current condition was reported to be stable.

Manufacturer Narrative

Block e1: initial reporter facility name: (b)(6) hospital.Block h6: imdrf device code a0413 captures the reportable event of silastic tube (silicon sleeve) on the ultraflex device fell inside the patient and was removed with forceps.Imdrf device code a15 captures the reportable event of stent partial deployment.

• 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: 17591752
• MDR Text Key: 321623504
• Report Number: 3005099803-2023-04475
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K012883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00564770
• Device Catalogue Number: 6477
• Device Lot Number: 0030040355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male