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

Model Number M00513830

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906); Appropriate Term/Code Not Available (3191)

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

Event Date 06/11/2021

Event Type  malfunction  

Manufacturer Narrative

The patient's exact age was not reported, however, the patient was reported to be over the age of 18.(b)(4).It is unknown if the device is expected to be returned for evaluation; therefore, a failure 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) 2021 that an ultraflex esophageal ng uncovered proximal release stent was to be implanted in the esophagus during a stent placement procedure for post-radiation esophagus squamous cell carcinoma performed on (b)(6) 2021.During the procedure, the stent could not be deployed.The procedure was not completed as another stent of the same size was unavailable.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation on (b)(6) 2021 that an ultraflex esophageal ng uncovered proximal release stent was to be implanted in the esophagus during a stent placement procedure for post-radiation esophagus squamous cell carcinoma performed on (b)(6) 2021.During the procedure, the stent could not be deployed.The procedure was not completed as another stent of the same size was unavailable.There were no patient complications reported as a result of this event.Additional information received on july 13, 2021.The ultraflex esophageal ng uncovered proximal release stent was partially covered by the black stent deployment suture when it was removed from the patient.

Manufacturer Narrative

Blocks b5 and h6 (device code) have been updated based on additional information received on july 13, 2021.Block a2: the patient's exact age was not reported, however, the patient was reported to be over the age of 18.Block h6: medical device problem code a27 is being used to capture the reportable issue of aborted/canceled procedure.Medical device problem code a15 captures the reportable event of a partially deployed ultraflex esophageal ng uncovered proximal release stent.Block h10: it is unknown if the device is expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12159337
• MDR Text Key: 261290475
• Report Number: 3005099803-2021-03506
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716204
• UDI-Public: 08714729716204
• Combination Product (y/n): N
• PMA/PMN Number: K091816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

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: 04/24/2022
• Device Model Number: M00513830
• Device Catalogue Number: 1383
• Device Lot Number: 0025468098
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 07/13/2021
• Supplement Dates Manufacturer Received: 07/13/2021
• Supplement Dates FDA Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1