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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 M00558370
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Failure to Deflate (4060)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/30/2023
Event Type  malfunction  
Manufacturer Narrative
Block h6: imdrf code a140101 captures the reportable event of balloon failure to deflate.
 
Event Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used during a procedure performed on (b)(6) 2023.It was reported that the balloon would not deflate.The device was cut out to be removed from the scope.No patient complications were reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Event Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used during a procedure performed on (b)(6) 2023.It was reported that the balloon would not deflate.The device was cut out to be removed from the scope.No patient complications were reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Manufacturer Narrative
Block h6: imdrf code a140101 captures the reportable event of balloon failure to deflate.Block h10: investigation results: the returned cre fixed wire dilatation balloon was analyzed, and a visual examination found that the balloon returned detached from the catheter with evidence of mechanical cut.Functional analysis could not be performed due to the returned condition of the device.Microscopic inspection found that the balloon returned detached from the catheter and the detached section has evidence of a mechanical cut.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event a balloon failure to deflate cannot be confirmed.The balloon returned detached from the catheter and the detached sections had evidence of a mechanical cut.This condition could have happened due to the reported event of the balloon not being able to get out of the scope and they cut the catheter and pushed the balloon out of the distal tip of the endoscope.Therefore, the most probable root cause is an adverse event related to procedure.
 
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Brand Name
CRE FIXED WIRE
Type of Device
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORK LIMITED
cork business technology park
model farm road
cork
EI  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key17393703
MDR Text Key319796101
Report Number3005099803-2023-04021
Device Sequence Number1
Product Code KNQ
UDI-Device Identifier08714729195993
UDI-Public08714729195993
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K971320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00558370
Device Catalogue Number5837
Device Lot Number0031072018
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/09/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/17/2023
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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