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

Model Number M00564760

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2015

Event Type  Injury  

Manufacturer Narrative

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 (b)(6) 2015 that an ultraflex tracheobronchial distal release covered stent was to be used in the right bronchi during a bronchi stent procedure performed on (b)(6) 2015.According to the complainant, this was to treat a 13.5mm malignant stricture.Reportedly, the patient's anatomy was not tortuous and was not pre dilated.During the procedure, after stent deployment in the right bronchi, the physician had difficulty removing the delivery system which caused the stent to move out of position.The catheter bowed and the stent had shifted from the right to the left bronchi.The stent was removed using biopsy forceps and the procedure was not completed due to this event.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

An ultraflex¿ tracheobronchial stent and delivery system were returned for analysis.Visual examination of the returned device found that the catheter was severely bent and kinked at the distal end.In addition, the deployment suture was found to be broken near the catheter¿s suture side port.No other issues were identified during the product analysis.Device analysis determined that the condition of the returned device was consistent with the complaint incident.The damage noted with the device were consistent with the application of excessive force to the delivery system.Therefore, the most probable root cause for this complaint is operational context.

Event Description

It was reported to boston scientific corporation on (b)(6) 2015 that an ultraflex tracheobronchial distal release covered stent was to be used in the right bronchi during a bronchi stent procedure performed on (b)(6) 2015.According to the complainant, this was to treat a 13.5mm malignant stricture.Reportedly, the patient's anatomy was not tortuous and was not pre dilated.During the procedure, after stent deployment in the right bronchi, the physician had difficulty removing the delivery system which caused the stent to move out of position.The catheter bowed and the stent had shifted from the right to the left bronchi.The stent was removed using biopsy forceps and the procedure was not completed due to this event.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: 5386060
• MDR Text Key: 36657011
• Report Number: 3005099803-2016-00086
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 12/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2017
• Device Model Number: M00564760
• Device Catalogue Number: 6476
• Device Lot Number: 17933546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2015
• 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
• Patient Outcome(s): Required Intervention