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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 M00513740
Device Problems Partial Blockage (1065); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/19/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device has not been received for analysis; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation on august 22, 2016 that an ultraflex esophageal stent was implanted in the esophagus during a stent placement procedure performed on (b)(6) 2016.The stent was used to treat a malignant stricture.There were no issues reported during initial stent placement.According to the complainant, on (b)(6) 2016, the patient experienced stent occlusion.It was also noted that the middle portion of the stent failed to expand.The stent was removed from the patient and the procedure was completed with another ultraflex esophageal 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.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
 
Manufacturer Narrative
Investigation results: only a fully deployed ultraflex esophageal stent was returned for analysis.A visual examination of the returned device found that there were multiple wire breaks, wires broken through the stent cover, and parts of stent wires were missing.Additionally, the stent was not fully expanded because some of the wire breaks were entangled with other side of the stent, restricting the lumen.No other issues were noted on the device.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 search of the complaint database confirmed that no similar complaints exist for the specified batch.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.The dfu lists ¿stent fracture¿ as a potential post-stent placement complication associated with the use of this device.Therefore, the root cause of this complaint is anticipated procedural complication.
 
Event Description
It was reported to boston scientific corporation on august 22, 2016 that an ultraflex esophageal stent was implanted in the esophagus during a stent placement procedure performed on (b)(6) 2016.The stent was used to treat a malignant stricture.There were no issues reported during initial stent placement.According to the complainant, on (b)(6) 2016, the patient experienced stent occlusion.It was also noted that the middle portion of the stent failed to expand.The stent was removed from the patient and the procedure was completed with another ultraflex esophageal 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.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
 
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Brand Name
ULTRAFLEX¿ ESOPHAGEAL NG
Type of Device
PROSTHESIS, ESOPHAGEAL
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 Key5947449
MDR Text Key54600268
Report Number3005099803-2016-02688
Device Sequence Number1
Product Code ESW
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K091816
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 08/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/06/2018
Device Model NumberM00513740
Device Catalogue Number1374
Device Lot Number0018776734
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/13/2016
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 Outcome(s) Required Intervention;
Patient Age79 YR
Patient Weight53
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