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

Model Number M00513750

Device Problems Kinked (1339); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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)(6) 2017 that an ultrafex esophageal ng distal release covered stent was to be used to treat an esophageal stricture during a stent placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the ultraflex stent was kinked from the middle and would not open one hour post-procedure.The physician tried to pass a guidewire to dilate the anatomy but the guidewire could not go through.The stent was pulled out.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.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

A fully deployed ultraflex esophageal ng distal release covered stent was returned for analysis.The delivery system was not returned.The stent was found to be compressed by its covering in the mid-section; however, the stent fully expanded after being submerged in hot water for five minutes.The stent was then measured to be within specifications.The investigation concluded that this complaint is associated with a product that meets specification.Dfu states: "a stent may require 24-72 hours to expand fully"; however, the customer expected a fully expanded stent 1 hour post-procedure.Therefore, the most probable root cause classification is design: product enhancement.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 confirmed that no similar complaints exist for the specified batch.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation on (b)(6) 2017 that an ultrafex esophageal ng distal release covered stent was to be used to treat an esophageal stricture during a stent placement procedure performed on (b)(6), 2017.According to the complainant, during the procedure, the ultraflex stent was kinked from the middle and would not open one hour post-procedure.The physician tried to pass a guidewire to dilate the anatomy but the guidewire could not go through.The stent was pulled out.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.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available a supplemental report will be submitted.

• 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: 6945627
• MDR Text Key: 89286073
• Report Number: 3005099803-2017-03080
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729649113
• UDI-Public: 08714729649113
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2017
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 18689829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2017
• Initial Date FDA Received: 10/12/2017
• Supplement Dates Manufacturer Received: 12/21/2017
• Supplement Dates FDA Received: 01/15/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 48