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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 M00558380
Device Problem Deflation Problem (1149)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2021 as no event date was reported.(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 an unknown date.During the removal of the balloon, it was noted that the balloon could not be fully deflated.Resultingly, the balloon ripped as soon as the catheter was pulled through the scope and left a bunched-up balloon on the end of the catheter which made it more difficult to remove the device from the scope.The device was pulled strongly from the scope, and the procedure was completed at this time.There were no patient complications as a result of this event.
 
Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2021 as no event date was reported.Problem code e2403 captures the reportable issue of balloon failed to deflate.Investigation results: a visual examination of the returned complaint device found that the balloon was detached and not returned.The shaft was detached and kinked in several sections.It was also noticed that the stainless steel was kinked and the black sleeve of the device was damaged.This problem could occur due to factors encountered during the procedure, such as the vacuum applied during the deflation was not sufficient and/or the interaction with the scope could have cause that the physician felt a lot of resistance causing the damages encountered in the catheter of the balloon.Also, the force applied during the removal of the balloon could have cause that the balloon was detached during the procedure.The most probable cause of this complaint is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
 
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 an unknown date.During the removal of the balloon, it was noted that the balloon could not be fully deflated.Resultingly, the balloon ripped as soon as the catheter was pulled through the scope and left a bunched-up balloon on the end of the catheter which made it more difficult to remove the device from the scope.The device was pulled strongly from the scope, and the procedure was completed at this time.There were no patient complications 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
MDR Report Key11604173
MDR Text Key243685948
Report Number3005099803-2021-01356
Device Sequence Number1
Product Code KNQ
UDI-Device Identifier08714729202011
UDI-Public08714729202011
Combination Product (y/n)N
PMA/PMN Number
K971320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/04/2021
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 Date11/30/2022
Device Model NumberM00558380
Device Catalogue Number5838
Device Lot Number0026435528
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2021
Initial Date Manufacturer Received 03/05/2021
Initial Date FDA Received04/01/2021
Supplement Dates Manufacturer Received04/09/2021
Supplement Dates FDA Received05/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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