MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE FIXED WIRE; DILATOR, ESOPHAGEAL

Model Number M00558360

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0504 captures the reportable event of a balloon leak in the esophagus.

Event Description

It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during a procedure performed on (b)(6) 2023.During the procedure, upon injecting saline during dilation at the stenosis, it was observed that the saline leaked from the side.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: imdrf device code a0504 captures the reportable event of a balloon leak in the esophagus.Block h10: investigation results the returned cre fixed wire dilatation balloon was analyzed, and a visual examination found that the balloon and catheter of the device had no damages.Functional analysis was performed, and the balloon was inflated without a problem; and it was able to hold the pressure without any problem.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon leak was not confirmed.The results of the analysis performed on the returned device found no visible damages to the device and after functional inspection the balloon was inflated without problem; and it was able to hold the pressure without any problem.Therefore, the most probable root cause is no problem detected.

Event Description

It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during a procedure performed on (b)(6) 2023.During the procedure, upon injecting saline during dilation at the stenosis, it was observed that the saline leaked from the side.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.

• 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 Key: 18521889
• MDR Text Key: 333145320
• Report Number: 3005099803-2023-07181
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 08714729195986
• UDI-Public: 08714729195986
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K971320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00558360
• Device Catalogue Number: 5836
• Device Lot Number: 0032178810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1