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

Model Number M00558350

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504); Use of Device Problem (1670)

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

Event Date 02/28/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during a balloon dilatation procedure performed on (b)(6) 2022.During the procedure, it was noted that there was a leakage on the device.The procedure was completed with another cre fixed wire dilatation balloon.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.There were no patient complications reported as a result of this event.Investigation results revealed that this balloon had a pinhole; therefore, this is now an mdr reportable event when used in the esophagus.

Manufacturer Narrative

Initial reporter phone: (b)(6).(b)(4).Investigation result: a visual examination of the returned complaint device found that the balloon and the catheter of device had no damages.A microscopic examination was performed and a balloon pinhole was found, which confirms the reported event of balloon leak.Functional analysis was performed, and the balloon was inflated without a problem; however, there was a pinhole in the distal section on the body of the balloon.Based on the evidence, it was reported that the physician pre-inflated the balloon before inserting in the working channel, this can provoke the pinhole found in the balloon, this problem can occur due to misuse of the dfu.Taking all available information into consideration, the most probable root cause is failure to follow instructions, since it was determined that the problems with the device can be traced to the user not following the manufacturer instructions.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was not used per the directions for use (dfu)/product label as the balloon was pre-inflated.

• 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: 14346404
• MDR Text Key: 291299004
• Report Number: 3005099803-2022-02475
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 08714729202004
• UDI-Public: 08714729202004
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: M00558350
• Device Catalogue Number: 5835
• Device Lot Number: 0027944532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• 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
• Patient Sex: Male