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

Model Number	M00513860
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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) 2016 that an ultraflex esophageal proximal release stent was to be used in the esophagus during a stent placement procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the stent was attempted to be deployed; however, once the stent was almost fully deployed (75% deployed) the stent was no longer able to be released.The physician suspected that the deployment suture was entangled.The partially deployed stent was removed from the patient 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 post- procedure was reported to be ¿no problem¿.
Additional Manufacturer Narrative
Investigation results: a partially deployed ultraflex esophageal stent and delivery system was received for analysis.Visual examination of the returned device found the deployment suture was broken and the part attached to the deployment pull ring was not returned.In addition, the shaft was significantly curved.Functional analysis found the stent was not possible to deploy as received due to the broken deployment suture but was possible to manually deploy the rest of the stent by pulling directly on the deployment suture.There was no issue with the stent and no other issues were identified during the product analysis.The investigation concluded that the observed failures are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause for this complaint is operational context.A review of the device history record (dhr) revealed no non-conforming events or deviations.A search of the complaint database confirmed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2016 that an ultraflex esophageal proximal release stent was to be used in the esophagus during a stent placement procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the stent was attempted to be deployed; however, once the stent was almost fully deployed (75% deployed) the stent was no longer able to be released.The physician suspected that the deployment suture was entangled.The partially deployed stent was removed from the patient 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 post- procedure was reported to be ¿no problem¿.

• Brand Name: ULTRAFLEX¿ ESOPHAGEAL NG
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6125387
• Report Number: 3005099803-2016-03599
• Device Sequence Number: 784323
• Product Code: ESW
• UDI-Device Identifier: 08714729716082
• UDI-Public: (01)08714729716082(17)20180112(10)18799059
• Combination Product (Y/N): N
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2016

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: 01/12/2018
• Device Model Number: M00513860
• Device Catalogue Number: 1386
• Device Lot Number: 18799059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/23/2016
• Supplement Report FDA Received Date: 03/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1