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

Model Number M00513860

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/04/2017

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 medwatch will be filed.

Event Description

It was reported to boston scientific corporation on july 16, 2017 that an ultraflex esophageal proximal release covered stent was to be used to treat a 12 cm stricture in the mid-esophagus during a stent placement procedure performed on (b)(6) 2017.Reportedly, the patient's anatomy had been dilated up to 11 mm prior to stent placement.According to the complainant, during the procedure, the physician was able to deploy the stent.However, when the stent was visualized with a scope, the stent was noted to be bent and the esophagus was completely blocked.The stent was removed from the patient and the procedure was completed with another ultraflex esophageal stent.The patient's condition at the conclusion of the procedure was reported to be stable.Attempts to obtain additional information regarding 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: 6768581
• MDR Text Key: 81901067
• Report Number: 3005099803-2017-02323
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716082
• UDI-Public: (01)08714729716082(17)20180614(10)0019367687
• Combination Product (y/n): N
• Reporter Country Code: BD
• 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: 07/16/2017

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: 06/14/2018
• Device Model Number: M00513860
• Device Catalogue Number: 1386
• Device Lot Number: 0019367687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2017
• Initial Date FDA Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 60