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

Model Number M00514250

Device Problems Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981)

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

Event Date 07/20/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device problem code a15 captures the reportable event of an ultraflex esophageal ng proximal release stent partially deployed.The complainant indicated that the ultraflex esophageal stent was discarded and will not be returned for evaluation; therefore, a device analysis of the complaint device could not be completed.If any further relevant information is identified, 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 to be implanted to treat a 7cm esophageal stricture during an upper gastrointestinal (ugi) endoscopy procedure performed on (b)(6) 2022.The patient's anatomy was tight and was dilated prior to stent placement.During the procedure, while trying to deploy the ultraflex esophageal stent, resistance was met and the shaft started to bend.When the ultraflex esophageal stent was partially released, the stent deployment suture became stuck and the ultraflex esophageal stent could not be deployed further.The ultraflex esophageal stent was removed from the patient partially deployed on the delivery system.The procedure was completed with a different device.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation on (b)(6) 2022, that an ultraflex esophageal ng proximal release covered stent was to be implanted to treat a 7cm esophageal stricture during an upper gastrointestinal (ugi) endoscopy procedure performed on (b)(6) 2022.The patient's anatomy was tight and was dilated prior to stent placement.During the procedure, while trying to deploy the ultraflex esophageal stent, resistance was met, and the shaft started to bend.When the ultraflex esophageal stent was partially released, the stent deployment suture became stuck, and the ultraflex esophageal stent could not be deployed further.The ultraflex esophageal stent was removed from the patient partially deployed on the delivery system.The procedure was completed with a different device.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: medical device problem code a15 captures the reportable event of an ultraflex esophageal ng proximal release stent partially deployed.Block h10: an ultraflex esophageal stent was received for analysis; the delivery system was not returned.The stent was received fully deployed and expanded.Visual examination of the returned device did not find any damages or issues to the stent.Product analysis did not confirm the reported event of stent partially deployed and shaft bent.There is no indication of what the customer reported because only the stent was returned completely deployed and had no visible problems.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.

• 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: 15188495
• MDR Text Key: 302928272
• Report Number: 3005099803-2022-04369
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716112
• UDI-Public: 08714729716112
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

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: 02/09/2024
• Device Model Number: M00514250
• Device Catalogue Number: 1425
• Device Lot Number: 0028834333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 08/08/2022
• Supplement Dates Manufacturer Received: 02/20/2023
• Supplement Dates FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2022
• 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 Age: 54 YR
• Patient Sex: Male
• Patient Weight: 48 KG