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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 Problem Deflation Problem (1149)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/28/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2021.During the procedure, it was noted that the balloon was unable to be deflated all the way down and needed to be cut to be removed from the scope.The procedure was completed at this time.There were no patient complications reported as a result of this event.
 
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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 Key12232637
MDR Text Key263862123
Report Number3005099803-2021-03756
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 company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 07/27/2021
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 Health Professional
Device Expiration Date03/12/2023
Device Model NumberM00558370
Device Catalogue Number5837
Device Lot Number0026961709
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/01/2021
Initial Date FDA Received07/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/12/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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