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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 M00565050
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/16/2014
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was used in the colon during a stent placement procedure performed on an unknown date.According to the complainant, during deployment of the stent, the blue outer sheath detached near the clear outer sheath of the stent.The stent failed to deploy and was removed from the patient.The procedure was completed with another wallflex enteral colonic 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 stable.
 
Manufacturer Narrative
Reported event of sheath partial detachment.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.
 
Event Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2014-02791 and 3005099803-2014-03158 for the other associated device information.It was reported to boston scientific corporation that two wallflex enteral colonic stents were used in the colon during a stent placement procedure performed on (b)(6) 2014.The stent was being used to treat a 15 cm neoplastic stenosis in the sigma colon.Reportedly, the patient had a normal colorectal anatomy.According to the complainant, during the procedure, when the physician attempted to deploy the first stent (the subject of mfr report #3005099803-2014-02791) the blue outer sheath detached near the clear outer sheath on the distal portion of the delivery system.The stent failed to deploy and was removed from the patient.When the physician attempted to deploy the second stent (the subject of mfr report #3005099803-2014-03158), the blue outer sheath detached near the handle and the stent failed to deploy.The procedure was not completed due to this event.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 stable.
 
Manufacturer Narrative
Additional information received august 26, 2014.Investigation results: a visual examination of the returned device found that the stent was received fully mounted onto the stent delivery system.The dark blue outer sheath was kinked 70mm distal to the distal handle.The bond between the dark blue outer sheath and the clear outer sheath had broken, making it impossible to deploy the stent.The investigator had no issue advancing and retracting the proximal inner with the distal handle.The shaft was dissected at the proximal end of the clear outer sheath.The distal end of the inner lumen and stent were withdrawn from the outer sheath and no issues were noted with their profiles.The proximal end of the inner sheath was withdrawn from the outer sheath and no issues were noted with its profile.The blue section of the outer sheath was dissected longitudinally and it was noted that some of the polytetrafluoroethylene (ptfe) coating had partially peeled away from the inside of the outer sheath.The noted damage to the delivery system is consistent with excessive force being applied to the delivery system.The damage is 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 performance specifications.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
 
Event Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2014-02791 and 3005099803-2014-03158 for the other associated device information.It was reported to boston scientific corporation that two wallflex enteral colonic stents were used in the colon during a stent placement procedure performed on (b)(6) 2014.The stent was being used to treat a 15 cm neoplastic stenosis in the sigma colon.Reportedly, the patient had a normal colorectal anatomy.According to the complainant, during the procedure, when the physician attempted to deploy the first stent (the subject of mfr report #3005099803-2014-02791) the blue outer sheath detached near the clear outer sheath on the distal portion of the delivery system.The stent failed to deploy and was removed from the patient.When the physician attempted to deploy the second stent (the subject of mfr report #3005099803-2014-03158), the blue outer sheath detached near the handle and the stent failed to deploy.The procedure was not completed due to this event.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 stable.
 
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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
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key4006197
MDR Text Key4777590
Report Number3005099803-2014-02791
Device Sequence Number1
Product Code MQR
Combination Product (y/n)N
Reporter Country CodeIT
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,Followup
Report Date 07/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/26/2016
Device Model NumberM00565050
Device Catalogue Number6505
Device Lot Number16849416
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/26/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/29/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age62 YR
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