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

Model Number M00564840

Device Problems Entrapment of Device (1212); Premature Activation (1484)

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

Event Date 11/22/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is unknown if the device will be returned for evaluation; therefore, a problem 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) 2021 that an ultraflex tracheobronchial covered distal release stent was to be implanted during a procedure performed on (b)(6) 2021.During the procedure, the stent deployed inside the rigid bronchoscope and the stent was unable to be removed from the scope.The procedure was completed with another scope and ultraflex tracheobronchial stent.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Blocks b5, d7a, e1 (initial reporter's phone number), and h8 have been updated with additional information received on january 21, 2022.Block h6: medical device problem code a150103 captures the reportable event of stent prematurely deployed inside the scope.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: it is unknown if the device will be returned for evaluation; therefore, a problem 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 december 13, 2021 that an ultraflex tracheobronchial covered distal release stent was to be implanted during a procedure performed on (b)(6), 2021.During the procedure, the stent deployed inside the rigid bronchoscope and the stent was unable to removed from the scope.The procedure was completed with another scope and ultraflex tracheobronchial stent.There were no patient complications reported as a result of this event.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Additional information received on january 21, 2022.The ultraflex tracheobronchial covered distal release stent was to be implanted in the right main bronchus during a rigid bronchoscopy procedure.

• 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: 13177348
• MDR Text Key: 283320088
• Report Number: 3005099803-2021-08124
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2023
• Device Model Number: M00564840
• Device Catalogue Number: 6484
• Device Lot Number: 0028090953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• 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