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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX? ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL
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BOSTON SCIENTIFIC - GALWAY WALLFLEX? ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL Back to Search Results
Model Number M00516750
Device Problem Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/24/2014
Event Type  Injury  
Event Description
It was reported to boston scientific corporation that a wallflex esophageal stent was used in the esophagus during a fistula closure procedure performed on (b)(6) 2014.According to the complainant, the physician deployed the stent to close the fistula and noticed that there were holes in the stent cover.The stent was removed and the procedure was completed with 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 fine.
 
Event Description
It was reported to boston scientific corporation that a wallflex esophageal stent was used in the esophagus during a fistula closure procedure performed on (b)(6) 2014.According to the complainant, the physician deployed the stent to close the fistula and noticed that there were holes in the stent cover.The stent was removed and the procedure was completed with 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 fine.
 
Manufacturer Narrative
The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.(b)(4).Although the suspect device has been received, 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 mdr will be filed.
 
Manufacturer Narrative
A visual examination of the returned device found the stent was deployed and fully expanded.It was noted that 2 endoscopic clips, that are used to secure the stent in the patient during the procedure were attached to the stent at the suture end.Multiple slits / holes were noted throughout the stent cover, however these holes were all smaller than 1.0mm in diameter which is within specification.No other issues were noted with the profile of the stent.The investigation concluded that this complaint is associated with a product that meets specification however the user is dissatisfied with the function, performance or appearance of the product.Therefore, the most probable root cause classification user preference issue.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.
 
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Brand Name
WALLFLEX? ESOPHAGEAL
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 Key3875044
MDR Text Key4564049
Report Number3005099803-2014-02286
Device Sequence Number1
Product Code ESW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091510
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00516750
Device Catalogue Number1675
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/28/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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