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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX ? DUODENAL; STENT,METALLIC,EXPANDABLE,DUODENAL
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BOSTON SCIENTIFIC - GALWAY WALLFLEX ? DUODENAL; STENT,METALLIC,EXPANDABLE,DUODENAL Back to Search Results
Model Number M00565030
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/20/2014
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a wallflex enteral duodenal stent was used in the duodenum during a stent placement procedure performed on (b)(6) 2014.According to the complainant, the stent was to be used to treat a 10cm stricture due to stomach cancer.Reportedly, the patient's anatomy was tortuous.During the procedure, the physician advanced the device to the target area and attempted to deploy the stent, however, resistance was encountered.A third of the stent was already deployed when the handle broke and detached from the outer sheath.Grasping the outer sheath directly, the physician tried to fully deploy the stent, but the stent could no longer be released.The physician then attempted to reconstrain the stent but could not do so.The partially deployed stent was then removed from the patient with the scope.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
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4) for the reported event of stent partially deployed.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 out that the stent was partially deployed by 22mm.It was noted that the stainless steel shaft was broken at 10mm from its proximal end and the shaft was broken at 1025mm from the distal handle.During the product analysis, the investigator noted that the proximal end of the outer sheath was stretched and that a piece of what appeared to be latex glove was stuck to the outside of the outer sheath beside the proximal handle.It was reported that the physician grasped the outer sheath directly while trying to release the stent; therefore, the piece of latex glove probably became attached to the outer sheath during this attempt.The piece of glove did not cause any restriction during deployment as it was on the outside of the outer sheath.It also didn¿t cause any resistance in movement of this section of the outer sheath during analysis.During analysis there was no issue in movement of the outer sheath along the proximal section of the shaft.The distal end of the inner was withdrawn from the distal end of the shaft and the stent was fully deployed.No issues were noted with the profile of the stent or the inner lumen.The blue section of the outer sheath was dissected longitudinally and it was noted that the polytetrafluoroethylene (ptfe) coating had partially peeled away from the inside of the outer sheath.The noted damage was likely due to procedural or anatomical factors encountered during the procedure such as tortuous anatomy or maneuvering of the device.Therefore, the most probable root cause for this complaint is operational context.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.
 
Event Description
It was reported to boston scientific corporation that a wallflex enteral duodenal stent was used in the duodenum during a stent placement procedure performed on (b)(6) 2014.According to the complainant, the stent was to be used to treat a 10cm stricture due to stomach cancer.Reportedly, the patient's anatomy was tortuous.During the procedure, the physician advanced the device to the target area and attempted to deploy the stent, however, resistance was encountered.A third of the stent was already deployed when the handle broke and detached from the outer sheath.Grasping the outer sheath directly, the physician tried to fully deploy the stent, but the stent could no longer be released.The physician then attempted to reconstrain the stent but could not do so.The partially deployed stent was then removed from the patient with the scope.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
WALLFLEX ? DUODENAL
Type of Device
STENT,METALLIC,EXPANDABLE,DUODENAL
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 Key4325319
MDR Text Key16308654
Report Number3005099803-2014-03888
Device Sequence Number1
Product Code MUM
Combination Product (y/n)N
PMA/PMN Number
K062750
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 11/20/2014
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 Date08/04/2016
Device Model NumberM00565030
Device Catalogue Number6503
Device Lot Number17173565
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/23/2015
Initial Date FDA Received12/12/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/12/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/07/2014
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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