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

Model Number M00558370

Device Problems Burst Container or Vessel (1074); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2019 as no event date was reported.(b)(4).Investigation results: a visual examination of the returned complaint device found that the balloon burst.It was also noticed that the catheter was kinked.Functional evaluation could not be performed due to the condition of the returned device.Dimensional examination of the catheter was performed and was measured in three sections; distal, medium and proximal.The three sections were within specification.Based on the available information, it is possible that factors encountered during the procedure, the technique used by the physician during the procedure, the amount of strength applied by the customer during the movement of the balloon, and/or the interaction between the scope and the balloon could have resulted in the damage found on the balloon.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used during a dilation procedure performed in the esophagus on an unknown date.According to the complainant, during the procedure, an attempt to inflate the balloon was made; however, the balloon would not inflate.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be okay.Investigation results revealed that the balloon burst; therefore, this is now an mdr reportable 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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9835323
• MDR Text Key: 191268761
• Report Number: 3005099803-2020-00832
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 08714729195993
• UDI-Public: 08714729195993
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2021
• Device Model Number: M00558370
• Device Catalogue Number: 5837
• Device Lot Number: 0024474702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Date Manufacturer Received: 02/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2019
• 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