• 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 M00558360
Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/14/2023
Event Type  malfunction  
Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of balloon catheter break.
 
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) 2023.During the procedure, the catheter broke into two separate pieces making it difficult to remove the balloon.The customer stated that no pieces of the device detached inside the patient.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications 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), 2023.During the procedure, the catheter broke into two separate pieces making it difficult to remove the balloon.The customer stated that no pieces of the device detached inside the patient.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications as a result of this event.
 
Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of balloon catheter break.Block h10: investigation results: the returned cre fixed wire dilatation balloon was analyzed, and a visual examination found that the catheter was kinked.Microscopic examination was performed and found that the catheter was kinked.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of catheter break was not confirmed.It was found that the catheter was kinked, not separated, or broken.Excessive manipulation of the device without enough care, excessive force during handling or usage, and/or forcing the device against significant resistance could induce device damages or loss of functionality.As the catheter break was not confirmed, the most probable root cause is no problem detected.
 
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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORK LIMITED
cork business technology park
model farm road
cork T12 Y K88
EI   T12 YK88
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key17690617
MDR Text Key322733528
Report Number3005099803-2023-04706
Device Sequence Number1
Product Code KNQ
UDI-Device Identifier08714729195986
UDI-Public08714729195986
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 10/23/2023
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 Model NumberM00558360
Device Catalogue Number5836
Device Lot Number0030531112
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/14/2023
Initial Date FDA Received09/06/2023
Supplement Dates Manufacturer Received09/28/2023
Supplement Dates FDA Received10/23/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-