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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX? COLONIC; STENT, COLONIC, METALIC, EXPANDABLE
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BOSTON SCIENTIFIC - GALWAY WALLFLEX? COLONIC; STENT, COLONIC, METALIC, EXPANDABLE Back to Search Results
Model Number M00565060
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/19/2014
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was used during a colonic stent placement procedure within the colon performed on (b)(6) 2014.During the procedure, outside the patient, the nurse attempted to deploy the stent a few centimeters and then reconstrain the stent prior inserting into the scope.When the nurse attempted to reconstrain the stent the handle broke, the stent could not be reconstrained and remained partially deployed.The procedure was completed with another wallflex enteral colonic stent.There were no patient complications reported as a result of this event.The patient condition was reported as ¿ no issues and no harm to the patient.¿.
 
Manufacturer Narrative
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 that the stent was partially deployed by 1mm.The outer sheath was broken at 2mm from its proximal end and the stainless steel shaft was bent.The inner was kinked at its distal end.During analysis it was possible to retract the outer sheath by hand and deploy the stent.No issues were noted with the profile of the stent.The shaft was dissected at the proximal end of the clear outer sheath.The inner lumen was withdrawn from the outer sheath and no issues were noted with its profile.The proximal end of the outer sheath was dissected longitudinally and it was noted that some of the polytetrafluoroethylene (ptfe) coating had partially peeled away from inside of the outer sheath.The investigation concluded that this complaint was caused by handling of the device or portion of the device without direct patient contact either during unpacking, preparation, or shipping; at the end of the procedure; or when packaging for return.Therefore, the most probable root cause classification for the reported failure is handling damage.A review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.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 colonic stent was used during a colonic stent placement procedure within the colon performed on (b)(6) 2014.During the procedure, outside the patient, the nurse attempted to deploy the stent a few centimeters and then reconstrain the stent prior inserting into the scope.When the nurse attempted to reconstrain the stent the handle broke, the stent could not be reconstrained and remained partially deployed.The procedure was completed with another wallflex enteral colonic stent.There were no patient complications reported as a result of this event.The patient condition was reported as ¿ no issues and no harm to the patient.¿.
 
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Brand Name
WALLFLEX? COLONIC
Type of Device
STENT, COLONIC, METALIC, EXPANDABLE
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer Contact
ingrid matte
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key3759398
MDR Text Key4420913
Report Number3005099803-2014-01737
Device Sequence Number1
Product Code MQR
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K061877
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 03/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2015
Device Model NumberM00565060
Device Catalogue Number6506
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/24/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/05/2013
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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