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

Model Number M00564860

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis; therefore a failure 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) 2017 that an ultraflex tracheobronchial distal release stent was to be used in the trachea to treat a 2 cm stenosis during a stent placement procedure performed on (b)(6) 2017.Reportedly, the patient¿s anatomy was not tortuous but was dilated prior to stent placement.According to the complainant, during the procedure, the physician was able to deploy the stent; however, the stent failed to expand.The stent got stuck in the delivery system and was removed together with the delivery system.The procedure was completed with a different device.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 fully deployed ultraflex tracheobronchial distal release stent and delivery system was returned for analysis.Visual examination of the returned device found the stent failed to expand on the distal end.Functional analysis found the stent still did not expand after incubating it at 37c for 24 hours.The complaint was confirmed, the stent did not fully expand on the distal end.The stent¿s failure to expand is likely attributed to the tight stitches on the distal end of the stent cover.As the event was most probably due to a bsc design specification that caused/contributed to problems in product use, the most probable root cause of this event is design.A review of the device history record (dhr) was performed and no deviations were found.A search of the complaint database confirmed that no similar complaints exist for the specified batch.

Event Description

It was reported to boston scientific corporation on (b)(6) 2017 that an ultraflex tracheobronchial distal release stent was to be used in the trachea to treat a 2cm stenosis during a stent placement procedure performed on (b)(6) 2017.Reportedly, the patient¿s anatomy was not tortuous but was dilated prior to stent placement.According to the complainant, during the procedure, the physician was able to deploy the stent; however, the stent failed to expand.The stent got stuck in the delivery system and was removed together with the delivery system.The procedure was completed with a different device.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: 6312317
• MDR Text Key: 66877187
• Report Number: 3005099803-2017-00352
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2017
• Device Model Number: M00564860
• Device Catalogue Number: 6486
• Device Lot Number: 18670980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2017
• Initial Date FDA Received: 02/08/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2015
• 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 Age: 23 YR
• Patient Weight: 60