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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRAFLEX ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL
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BOSTON SCIENTIFIC CORPORATION ULTRAFLEX ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL Back to Search Results
Model Number M00513750
Device Problem Unraveled Material (1664)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/05/2018
Event Type  Injury  
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 Description
It was reported to boston scientific corporation on (b)(6) 2018 that an ultraflex esophageal ng distal release covered stent was to be used to treat a stenosis caused by tumor during a procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the stent was successfully placed in the stenosis.Reportedly, when re-entering the esophagus for post-placement inspection, two wires at the proximal end of the stent were confirmed loose.The stent was removed from the patient and the procedure was not completed.There were no patient complications reported as a result of this event.Note: despite numerous attempts boston scientific has been unable obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.
 
Manufacturer Narrative
A deployed ultraflex esophageal ng stent was received for analysis; the delivery system was not returned.Visual examination of the returned device found the stent was unraveled.The stent was measured to be within specifications.No other issues were noted to the stent.The reported event of stent unraveled was confirmed.The investigation concluded that procedural factors encountered during the procedure or the technique of the user, could have affected the device performance.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 released for distribution.
 
Event Description
It was reported to boston scientific corporation on (b)(6) 2018 that an ultraflex esophageal ng distal release covered stent was to be used to treat a stenosis caused by tumor during a procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the stent was successfully placed in the stenosis.Reportedly, when re-entering the esophagus for post-placement inspection, two wires at the proximal end of the stent were confirmed loose.The stent was removed from the patient and the procedure was not completed.There were no patient complications reported as a result of this event.Note: despite numerous attempts boston scientific has been unable obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.
 
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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 Key8030269
MDR Text Key125868530
Report Number3005099803-2018-61157
Device Sequence Number1
Product Code ESW
UDI-Device Identifier08714729649113
UDI-Public08714729649113
Combination Product (y/n)N
PMA/PMN Number
K091816
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/07/2020
Device Model NumberM00513750
Device Catalogue Number1375
Device Lot Number0021834136
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2018
Date Manufacturer Received01/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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