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

Model Number M00514250

Device Problem Knotted (1340)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results: the ultraflex esophageal stent and the delivery system were returned for analysis.The stent was not deployed.Visual examination of the returned device found the shaft was curved.Functional evaluation found the pull ring broke off during an attempted deployment.It was not possible to manually deploy the stent by pulling directly on the deployment suture.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.It was not possible to manually deploy the stent due to a knot that was noted on the proximal end of the deployment suture which prohibits the release of the stent.Taking into consideration the evaluation during investigation and the details of the complaint, this investigation is assigned the most probable root cause classification of manufacturing.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.A search of the complaint database revealed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that an ultraflex esophageal proximal release stent was to be used in the esophagus to treat a malignant tumor during a stent placement procedure performed on (b)(6) 2017.According to the complainant, the patient's anatomy was tortuous.According to the complainant, during the procedure, the stent could not be released.The device was removed from the patient and the procedure was completed with another ultraflex esophageal 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 esophageal proximal release stent deployment suture was knotted.

• 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: 6541370
• MDR Text Key: 74320424
• Report Number: 3005099803-2017-01338
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716112
• UDI-Public: (01)08714729716112(17)20180902(10)19673973
• Combination Product (y/n): N
• Reporter Country Code: ZA
• 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
• Report Date: 04/15/2017

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: 09/02/2018
• Device Model Number: M00514250
• Device Catalogue Number: 1425
• Device Lot Number: 19673973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2017
• Initial Date FDA Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2016
• 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