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

Model Number	M00513850
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2018
Type of Reportable Event	Malfunction
Additional 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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that an ultraflex esophageal proximal release covered stent was to be used to treat a malignant stricture in the esophagus during esophageal stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure the stent was able to cross the stenosis along with the guidewire.However, it was reported that great resistance was met during deployment, and the stent was deployed partially on the delivery system.The stent was removed 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 following the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6), 2018 that an ultraflex esophageal proximal release covered stent was to be used to treat a malignant stricture in the esophagus during esophageal stent placement procedure performed on (b)(6), 2018.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure the stent was able to cross the stenosis along with the guidewire.However, it was reported that great resistance was met during deployment, and the stent was deployed partially on the delivery system.The stent was removed 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 following the procedure was reported to be stable.
Additional Manufacturer Narrative
Problem code 2906 captures the reportable event of ultraflex esophageal proximal release stent was partially deployed on the delivery system.A deployed ultraflex esophageal ng proximal release covered stent and delivery system were returned for analysis.Visual examination of the returned device identified no issues with the stent and delivery system.The stent was measured to be within specifications.The complainant confirmed the stent was fully deployed by the physician outside the patient and prior to returning the device for analysis.Taking all available information into consideration, the investigation concluded that most likely anatomical or procedural factors encountered during the procedure may have limited the performance of the device.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.

• 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: 8005618
• Report Number: 3005099803-2018-60993
• Device Sequence Number: 289159
• Product Code: ESW
• UDI-Device Identifier: 08714729716075
• UDI-Public: 08714729716075
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2018

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: 03/15/2020
• Device Model Number: M00513850
• Device Catalogue Number: 1385
• Device Lot Number: 0021870807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Received by Manufacturer: 09/29/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1