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

Model Number M00564900

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An ultraflex tracheobronchial covered stent was received for analysis; the delivery system was not returned.The stent was received deployed and expanded.Visual examination of the returned device found the green stent retention suture was broken.No other issues with the stent were noted.It was reported that the deployment suture was entangled with the stent during the procedure.The broken stent retention suture noted on the returned stent may potentially be a result of resistance encountered during the manipulation of the deployment suture during the attempted deployment.Given the event description and the condition of the returned device, the investigation concluded that observed failure was likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A search of the complaint database confirmed that no other similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that an ultraflex tracheobronchial covered distal release stent was to be used in the airway during a stent placement procedure performed on (b)(6) 2018.According to the complainant, during stent deployment, it was difficult to pull the stent deployment suture; resistance was felt and the stent was unable to be fully released inside the patient.The stent was removed from the patient partially deployed on the delivery system.After withdrawal, it was noted that the deployment suture had entangled with the tip of the stent.The procedure was completed with another ultraflex tracheobronchial stent.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.Note: this event has been deemed a mdr reportable event based on the investigation results which revealed that the stent retention suture was broken.

• 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: 7668772
• MDR Text Key: 113391932
• Report Number: 3005099803-2018-02195
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: M00564900
• Device Catalogue Number: 6490
• Device Lot Number: 21080560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2017
• 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 Age: 65 YR
• Patient Weight: 67