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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ULTRAFLEX? ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL
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BOSTON SCIENTIFIC - GALWAY ULTRAFLEX? ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL Back to Search Results
Model Number M00513710
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/27/2014
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that an ultraflex esophageal distal release stent was to be used in the lower esophagus during an esophageal stent placement procedure performed on (b)(6) 2014.According to the complainant, this was to treat a stricture due to esophageal cancer.Reportedly, the patient's anatomy was tortuous.During the procedure, the physician advanced the device to the target area and attempted to release the stent, however, resistance was encountered when pulling the suture.The stent was unable to be released and was removed from the patient.It was unknown whether the stent was removed from the patient partially deployed; however, the physician did partially deploy the device outside the patient once it was removed.The procedure was completed with an ultraflex esophageal proximal release stent.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 good.
 
Manufacturer Narrative
(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Manufacturer Narrative
A visual examination of the returned device found that the stent was partially deployed by 25mm.It was noted that the delivery catheter was kinked 330mm from the hub.No issues were noted with the profile of stitches from the point of release from the stent.During analysis it was possible to retract the deployment suture and fully deploy the stent without issue.The noted damages indicate difficulty was experienced during deployment and are likely due to anatomical or procedural factors such as tortuous anatomy or maneuvering of the device.Therefore, a review and analysis of all available information indicated that the most probable root cause is operational context.A review of the device history record (dhr) was performed; no anomalies were noted.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.
 
Event Description
It was reported to boston scientific corporation that an ultraflex esophageal distal release stent was to be used in the lower esophagus during an esophageal stent placement procedure performed on (b)(6) 2014.According to the complainant, this was to treat a stricture due to esophageal cancer.Reportedly, the patient's anatomy was tortuous.During the procedure, the physician advanced the device to the target area and attempted to release the stent, however, resistance was encountered when pulling the suture.The stent was unable to be released and was removed from the patient.It was unknown whether the stent was removed from the patient partially deployed; however, the physician did partially deploy the device outside the patient once it was removed.The procedure was completed with an ultraflex esophageal proximal release stent.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 good.
 
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Brand Name
ULTRAFLEX? ESOPHAGEAL NG
Type of Device
PROSTHESIS, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key4343266
MDR Text Key21720621
Report Number3005099803-2014-03963
Device Sequence Number1
Product Code ESW
Combination Product (y/n)N
PMA/PMN Number
K091816
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/27/2014
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
Device Operator Health Professional
Device Expiration Date06/24/2016
Device Model NumberM00513710
Device Catalogue Number1371
Device Lot Number0017075982
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/19/2015
Initial Date FDA Received12/18/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/11/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/02/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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