MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRAFLEX ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL

Model Number M00513860

Device Problems Difficult or Delayed Positioning (1157); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon completion of the problem 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 (b)(6) 2022 that an ultraflex esophageal ng proximal release covered stent was used to treat an esophageal stricture during an oesophago-gastro-duodenoscopy (ogd) with stent placement procedure performed on (b)(6) 2022.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent deployment suture could not be pulled out and it was noticed through imaging that the stent was deployed at the incorrect location.The stent was removed from the patient with forceps 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.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14428369
• MDR Text Key: 291930806
• Report Number: 3005099803-2022-02541
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716082
• UDI-Public: 08714729716082
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K091816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2022

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: 01/07/2024
• Device Model Number: M00513860
• Device Catalogue Number: 1386
• Device Lot Number: 0028640802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2022
• 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