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

Model Number M00558370

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)

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

Event Date 08/01/2021

Event Type  malfunction  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date (b)(6) 2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).A visual examination of the returned complaint device found the balloon portion of the device was not returned.The catheter was noted to be kinked.Microscopic analysis was performed, and it was noticed that the black sleeve had a little gap.During the microscope inspection the balloon was dissected to inspect the outer diameter (od) (distal-medium-proximal) and no defects were noted.The observed failures are likely due to factors encountered during the procedure, such as interaction with scope or any other surface during the procedure inside of the anatomy that could create friction on the balloon that caused the black sheath to have a small gap with the catheter and the catheter to kink, leading to the balloon detachment.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

Boston scientific corporation received a cre fixed wire dilation balloon device with no associated information.This event has been deemed reportable on (b)(6) 2021 based on the investigation results of balloon detached.

• 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: 12415404
• MDR Text Key: 269584421
• Report Number: 3005099803-2021-04547
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 08714729195993
• UDI-Public: 08714729195993
• Combination Product (y/n): N
• PMA/PMN Number: K971320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2023
• Device Model Number: M00558370
• Device Catalogue Number: 5837
• Device Lot Number: 0026979594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Date Manufacturer Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1