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

Model Number M00513750

Device Problem Knotted (1340)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation result of stent suture knotted.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation on (b)(4) 2015 that an ultraflex esophageal ng distal release stent was used in the esophagus during a procedure performed on (b)(6) 2015.According to the complainant, the stent was to be used to treat a 5cm malignant tumor.Reportedly, the patient's anatomy was not tortuous andࠔhe patient's anatomy had not been dilated prior to stent placement.According to the complainant, during the procedure, the stent suture was found to be knotted and the stent failed to deploy.The procedure was completed with another ultraflex esophageal ng distal release 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

An ultraflex¿ esophageal distal release stent and delivery system were returned for analysis.Visual examination of the returned device found that approximately 1mm of the very proximal end of the stent was not deployed.A visual and microscopic examination found no issue with the stent suture and the stent crochet.During the product analysis, the investigator was able to fully deploy the stent with no restrictions noted.No other issues were identified during the product analysis.Device analysis determined that the noted damage is likely due to anatomical or procedural factors.Therefore, a review and analysis of all available information indicated that the most probable root cause 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) was performed and no deviations were found.A search of the complaint database revealed that no other complaints exist for the specified batch.

Event Description

It was reported to boston scientific corporation on (b)(4) 2015 that an ultraflex esophageal ng distal release stent was used in the esophagus during a procedure performed on (b)(6) 2015.According to the complainant, the stent was to be used to treat a 5cm malignant tumor.Reportedly, the patient's anatomy was not tortuous and the patient's anatomy had not been dilated prior to stent placement.According to the complainant, during the procedure, the stent suture was found to be knotted and the stent failed to deploy.The procedure was completed with another ultraflex esophageal ng distal release 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¿ 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: 5205538
• MDR Text Key: 30574537
• Report Number: 3005099803-2015-03000
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K091816
• 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: 10/13/2015

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: 07/01/2017
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 18158363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2015
• Initial Date FDA Received: 11/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2015
• 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