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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE FIXED WIRE; DILATOR, ESOPHAGEAL
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BOSTON SCIENTIFIC CORPORATION CRE FIXED WIRE; DILATOR, ESOPHAGEAL Back to Search Results
Model Number M00558350
Device Problems Device Operates Differently Than Expected (2913); Improper Flow or Infusion (2954)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/27/2017
Event Type  malfunction  
Event Description
Patient undergoing an esophagogastroduodenoscopy with thru the scope balloon dilation.When this is done a fixed wire is inserted and syringe gauge assembly is used for the dilation.Staff report that the gauge went down to zero, but the fluid was going into the balloon.They changed out the syringe and it happened again, they changed out the balloon and same thing happened.They went thru 4 syringes, 2 inflation devices and 2 balloons, eventually completing the procedure.No harm to patient.Per site reporter: endo staff called the boston scientific rep for the device and sent the devices to rep.We have not heard back yet.Sent tubes, gastrointestinal (and accessories), to the alliance ii rep, no response yet.
 
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Brand Name
CRE FIXED WIRE
Type of Device
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
marlborough MA 01752
MDR Report Key6812640
MDR Text Key83363988
Report Number6812640
Device Sequence Number1
Product Code KNQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 08/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2017
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberM00558350
Device Catalogue NumberM00558350
Device Lot Number20547835
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/03/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer08/03/2017
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
Treatment
ENDOSCOPE
Patient Age30 YR
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