MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ULTRAFLEX¿ ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL

Model Number M00513750

Device Problems Knotted (1340); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the investigation result of stent partially deployed.(b)(4) the investigation result of stent suture knotted.Investigation results: an ultraflex¿ esophageal ng stent and delivery system were returned for analysis.Visual examination of the returned device found that the stent was partially deployed.A circumferential knot was found at the distal end of the crocheted deployment suture that made deployment impossible.During product analysis, the knot around the catheter shaft was untied and the stent was successfully deployed.The catheter profile was inspected and no issues were noted.No other issues were identified during the product analysis.Device analysis determined that the condition of the returned device was not consistent with the complaint incident; the device was returned partially deployed.The cause of the noted device defect was most likely 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) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.

Event Description

It was reported to boston scientific corporation on (b)(6) 2015 that an ultraflex esophageal ng stent was to be used to treat a malignant stricture in the esophagus during a stent placement procedure performed on (b)(6) 2015.Reportedly, the lesion was not dilated prior to the stent placement procedure.During the procedure, the ultraflex esophageal ng stent failed to deploy.The stent was removed from the patient fully constrained and the procedure was completed with another ultraflex esophageal ng 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 an mdr-reportable event based on investigation results which revealed that the ultraflex stent was partially deployed and a circumferential knot at the distal end of the crocheted deployment suture.

• Brand Name: ULTRAFLEX¿ ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• 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: 5526247
• MDR Text Key: 41167116
• Report Number: 3005099803-2016-00851
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K091816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2016

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: 08/06/2016
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 17182074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2016
• Initial Date FDA Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2014
• 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: 50 YR