Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE FIXED WIRE; DILATOR, ESOPHAGEAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 04/06/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, 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 esophageal dilation procedure performed on (b)(6) 2021.During the procedure, the balloon would not completely deflate.The syringe was then removed from the balloon, and the water inside was discarded.The syringe was reattached to the inflator, but the balloon would still not deflate.The device was removed with the scope from the patient, and the device was cut in order to be removed from the scope.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during an esophageal dilation procedure performed on (b)(6) 2021.During the procedure, the balloon would not completely deflate.The syringe was then removed from the balloon, and the water inside was discarded.The syringe was reattached to the inflator, but the balloon would still not deflate.The device was removed with the scope from the patient, and the device was cut in order to be removed from the scope.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: device code a1401 captures the reportable event of balloon failed to deflate.Block h10: investigation results: a visual examination of the returned complaint device found that the catheter was detached in two sections.It was also noted that the catheter was kinked and the balloon was not returned with the device.Microscopic analysis was performed, and it was confirmed that the catheter was cut.The reported event of balloon failed to deflate was confirmed based on the found failure of catheter kinked which probably affected the deflation time thus, the device had to be cut.This failure is likely due to factors encountered during the procedure, such as the interaction between the device with the scope, and normal procedural difficulties encountered during the procedure could have possibly affected the device performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure and the device had no influence on event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11766292
MDR Text Key248707153
Report Number3005099803-2021-01950
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 06/11/2021
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 Date02/15/2023
Device Model NumberM00558380
Device Catalogue Number5838
Device Lot Number0026809775
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2021
Initial Date Manufacturer Received 04/06/2021
Initial Date FDA Received05/03/2021
Supplement Dates Manufacturer Received05/14/2021
Supplement Dates FDA Received06/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-