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

Model Number	M00513830
Medical Device Problem Codes	Positioning Failure (1158); Activation, Positioning or Separation Problem (2906); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12159337
• Report Number: 3005099803-2021-03506
• Device Sequence Number: 4723473
• Product Code: ESW
• UDI-Device Identifier: 08714729716204
• UDI-Public: 08714729716204
• Combination Product (Y/N): N
• Initial Reporter Country: MO
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1