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

Model Number M00564800

Device Problems Positioning Problem (3009); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on june 15, 2017 that an ultraflex tracheobronchial distal release stent was to be used to treat a malignant stricture in the left principal bronchus during a stent placement procedure performed on (b)(6) 2017.Reportedly, the patient¿s anatomy was tight.According to the complainant, after deployment, the stent failed to expand to the needed diameter and it slipped off from the target area.The stent was retrieved using forceps and 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.

Manufacturer Narrative

Investigation results: a deployed ultraflex tracheobronchial stent, shaft, and detached deployment suture/ring were returned for analysis.Visual analysis of the returned device found the shaft was kinked.The stent was measured to be within specifications.There were no issues identified with the device.The investigation concluded that the reported event was likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device, such as tight anatomy.Therefore, the most probable root cause for this complaint is operational context.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.A review of the device history record (dhr) revealed no non-conforming events or deviations.A search of the complaint database confirmed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation on june 15, 2017 that an ultraflex tracheobronchial distal release stent was to be used to treat a malignant stricture in the left principal bronchus during a stent placement procedure performed on (b)(6) 2017.Reportedly, the patient¿s anatomy was tight.According to the complainant, after deployment, the stent failed to expand to the needed diameter and it slipped off from the target area.The stent was retrieved using forceps and 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.

• Brand Name: ULTRAFLEX¿ TRACHEOBRONCHIAL
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6691020
• MDR Text Key: 79232102
• Report Number: 3005099803-2017-02012
• 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,Followup
• Report Date: 06/15/2017

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: 05/25/2018
• Device Model Number: M00564800
• Device Catalogue Number: 6480
• Device Lot Number: 0019299095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 07/06/2017
• Supplement Dates Manufacturer Received: 08/02/2017
• Supplement Dates FDA Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2016
• 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
• Patient Age: 57 YR
• Patient Weight: 48