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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ULTRAFLEX¿ ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL
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BOSTON SCIENTIFIC - GALWAY ULTRAFLEX¿ ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL Back to Search Results
Model Number M00513750
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Patient Involvement (2645)
Event Date 05/26/2015
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that an ultraflex¿ esophageal ng stent was going to be used during an esophageal stent implantation procedure performed on (b)(6) 2015.According to the complainant, while unpacking the ultraflex¿ esophageal ng stent, the physician noted that the stent was partially deployed.This device was not used on the patient.The procedure was completed with another ultraflex¿ esophageal ng 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 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
An ultraflex esophageal ng stent was received; the device was received with the stent partially deployed.The distal stent loops were deployed and the distal end of the deployment suture was detached from the silastic tubing.Analysis determined that the condition of the returned device was consistent with the complaint incident.No issues were noted with the profile of the remaining crocheted section of the stent or of the delivery device.Given the event description and the condition of the returned device, the noted issues were likely 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 is handling damage.A review of the device labeling and directions for use (dfu) was performed and no anomalies were noted.
 
Event Description
It was reported to boston scientific corporation that an ultraflex¿ esophageal ng stent was going to be used during an esophageal stent implantation procedure performed on (b)(6) 2015.According to the complainant, while unpacking the ultraflex¿ esophageal ng stent, the physician noted that the stent was partially deployed.This device was not used on the patient.The procedure was completed with another ultraflex¿ esophageal ng 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
ULTRAFLEX¿ ESOPHAGEAL NG
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 Key4862491
MDR Text Key17587405
Report Number3005099803-2015-01696
Device Sequence Number1
Product Code ESW
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
K091816
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,company represent
Reporter Occupation Other
Type of Report Initial
Report Date 05/27/2015
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 Physician
Device Expiration Date12/12/2015
Device Model NumberM00513750
Device Catalogue Number1375
Device Lot Number16604561
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/27/2015
Initial Date FDA Received06/23/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age63 YR
Patient Weight56
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