MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ULTRAFLEX¿ ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL

Model Number	M00514250
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device code relates to problem code for the reported event of stent partially deployed.The device has not been received for analysis; 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) 2017 that an ultraflex esophageal proximal release covered stent was to be used to treat a gastroesophageal junction stricture due to esophageal cancer during a stenting procedure performed on (b)(6) 2017.Reportedly, the patient's anatomy was not tortuous.According to the complainant, during the procedure, the physician started deploying the stent, however, the shaft was kinked and the stent was partially deployed.The procedure was completed a different device.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.
Additional Manufacturer Narrative
A partially deployed ultraflex esophageal proximal release covered stent and delivery system was received for analysis.Visual examination of the returned device observed manipulation near the distal part.Functional analysis of the device found that the stent was able to be deployed without any resistance.The stent was measured to be within specifications.No issues noted with the green braided polyester suture and no other issues noted with the device.The damages noted with the device were consistent with the application of excessive force during usage.The investigation concluded that the cause of the reported event was most probably due to anatomical or procedural factor encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.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.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2017 that an ultraflex esophageal proximal release covered stent was to be used to treat a gastroesophageal junction stricture due to esophageal cancer during a stenting procedure performed on (b)(6) 2017.Reportedly, the patient's anatomy was not tortuous.According to the complainant, during the procedure, the physician started deploying the stent, however, the shaft was kinked and the stent was partially deployed.The procedure was completed a different device.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
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7160717
• Report Number: 3005099803-2017-03928
• Device Sequence Number: 63651
• Product Code: ESW
• UDI-Device Identifier: 08714729716112
• UDI-Public: 08714729716112
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 12/13/2017

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: 01/09/2019
• Device Model Number: M00514250
• Device Catalogue Number: 1425
• Device Lot Number: 0020137743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1