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

Model Number M00558380

Device Problems Leak/Splash (1354); Material Deformation (2976)

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

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

Block e1: the initial reporter facility name: (b)(6).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 an esophageal dilation procedure performed on (b)(6)2023.During the procedure, there was a leak from the front of the balloon, and the balloon could not be dilated to the specified dilation diameter.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 e1: the initial reporter facility name: (b)(6).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 no damages to the catheter of the device.The balloon of the device was carefully inspected, and it was found damaged.Microscopic inspection found a longitudinal tear from the tip of the balloon until the proximal section.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon leak was confirmed.The results of the analysis performed on the returned device found that the balloon had a longitudinal tear from the tip of the balloon, until the proximal section of it which caused leakage in the balloon.The longitudinal tear found in the balloon is likely to have occurred due to factors encountered during the procedure, it can be due to excess pressure, interaction with other devices, or anatomical factors.These factors and interactions could influence the damage found in the balloon.Also, it is possible that interaction with any kind of a sharp surface during or previous the procedure could create friction on the balloon, causing the problem of longitudinal tear during the procedure.Therefore, the most probable root cause is an adverse event related to procedure.

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, there was a leak from the front of the balloon, and the balloon could not be dilated to the specified dilation diameter.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: 18387272
• MDR Text Key: 331491400
• Report Number: 3005099803-2023-06851
• Device Sequence Number: 1
• Product Code: KNQ
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00558380
• Device Catalogue Number: 5838
• Device Lot Number: 0030592559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2022
• 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