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

Model Number M00564520

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results: a partially deployed ultraflex tracheobronchial distal release stent was received for analysis.Visual examination of the returned device found the shaft was curved and bowed during deployment.In addition, one wire loop on the proximal end of the stent was broken.Functional analysis found the stent was possible to deploy as received.There were no other issues identified during the product analysis.Device analysis determined that the condition of the returned device was consistent with the complaint incident, the stent partially deployed.It is likely that the wire loop of the stent broke during removal of the device.The cause of the reported event and the noted device defects was most probably due to anatomical or procedural factors encountered during the procedure.Therefore, the most probable root cause for this complaint is operational context.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 that an ultraflex tracheobronchial uncovered distal release stent was to be used to treat an approximately 2.5 cm long extrinsic tumor in the proximal part of the lung in the right main bronchus during a stent placement procedure performed on (b)(6) 2017.Reportedly, patient¿s anatomy was not tortuous and was dilated prior to stent placement.According to the complainant, during the procedure, the shaft bowed and kinked, and the stent deployment suture could no longer be pulled.It was confirmed through x-ray that the stent moved unintendedly to the distal portion of the trachea.The physician removed the partially deployed stent from the patient.The patient¿s airway mucosa suffered inflammation and abrasion by the partially deployed stent; however, no intervention was performed to address the trauma.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 an mdr-reportable event based on investigation results which revealed that one wire loop on the proximal end of the stent was broken.

• 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: 6637249
• MDR Text Key: 77540440
• Report Number: 3005099803-2017-01682
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2017
• Device Model Number: M00564520
• Device Catalogue Number: 6452
• Device Lot Number: 18193229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2015
• 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