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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 Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/21/2016
Event Type  malfunction  
Manufacturer Narrative
(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.
 
Event Description
It was reported to boston scientific corporation on (b)(6) 2016 that a wallflex enteral colonic stent was to be used in the sigmoid colon during a stent implantation procedure performed on (b)(6) 2016.According to the complainant, during preparation, the physician found that the tip of the stent was bent.The device was not used and 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
A wallflex¿ colonic stent and delivery system were returned for analysis.Visual examination of the returned device found that the stent was partially deployed.There is a slight bend and accordion in the clear outer sheath.In addition, the stainless steel tube was kinked.There were no issues noted with the inner shaft or the profile of the stent.During functional analysis, it was not possible to deploy the device as returned.It was possible to manually deploy the stent after dissection.No other issues were identified during the product analysis.The noted damages to the returned device were consistent with excessive force being applied 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.
 
Event Description
It was reported to boston scientific corporation on (b)(6) 2016 that a wallflex enteral colonic stent was to be used in the sigmoid colon during a stent implantation procedure performed on (b)(6) 2016.According to the complainant, during preparation, the physician found that the tip of the stent was bent.The device was not used and 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.
 
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Brand Name
WALLFLEX¿ COLONIC
Type of Device
STENT, COLONIC, METALIC, EXPANDABLE
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key5432056
MDR Text Key38081024
Report Number3005099803-2016-00242
Device Sequence Number1
Product Code MQR
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
K061877
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/17/2017
Device Model NumberM00565050
Device Catalogue Number6505
Device Lot Number0017799848
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/17/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/20/2015
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 Age78 YR
Patient Weight89
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