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

Model Number M00558380

Device Problems Detachment of Device or Device Component (2907); Device Misassembled During Manufacturing /Shipping (2912); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/04/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable investigation result of balloon detachment.Block h10: investigation results the returned cre fixed wire dilatation balloon was analyzed, and a visual examination found that the balloon was not returned for this complaint and only the catheter was returned.The catheter was inspected, and no damages were noted.In the proximal section can be observed the proximal bond with irregular shape.The coil of the device can be observed stretched in the distal section.Microscopic inspection found that the coil of the device can be observed the wire stretched in the distal section and in the proximal section can be observed the proximal bond with irregular shape.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of device misassembled during manufacturing or shipping cannot be confirmed.The device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.After analysis, it was determined that the coil of the device can be observed the wire stretched in the distal section.Additionally, in the proximal section can be observed the proximal bond with irregular shape.That is evidence that the balloon was detached.Most likely procedural factors as lesion characteristics, handling of the device, the technique used by the physician (force applied), could have resulted in the damages encountered in the device.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 a dilation procedure performed on (b)(6) 2023.During the procedure, the cre fixed wire dilatation balloon was shipped without the pebax balloon material and only just a wire sticking out of the catheter.A photo submitted by the customer showed the wire sticking out of the catheter without the balloon material.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of a balloon detached.Please see block h10 for full investigation details.

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable investigation result of balloon detachment.Block h10: investigation results: the returned cre fixed wire dilatation balloon was analyzed, and a visual examination found that the balloon was not returned for this complaint and only the catheter was returned.The catheter was inspected, and no damages were noted.In the proximal section can be observed the proximal bond with irregular shape.The coil of the device can be observed stretched in the distal section.Microscopic inspection found that the coil of the device can be observed the wire stretched in the distal section and in the proximal section can be observed the proximal bond with irregular shape.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of device misassembled during manufacturing or shipping cannot be confirmed.The device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.After analysis, it was determined that the coil of the device can be observed the wire stretched in the distal section.Additionally, in the proximal section can be observed the proximal bond with irregular shape.That is evidence that the balloon was detached.Most likely procedural factors as lesion characteristics, handling of the device, the technique used by the physician (force applied), could have resulted in the damages encountered in the device.Therefore, the most probable root cause is an adverse event related to procedure.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/product label.

Event Description

It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during a dilation procedure performed on (b)(6) 2023.During the procedure, the cre fixed wire dilatation balloon was shipped without the pebax balloon material and only just a wire sticking out of the catheter.A photo submitted by the customer showed the wire sticking out of the catheter without the balloon material.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of a balloon detached.Please see block h10 for full investigation details.

• 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: 18088958
• MDR Text Key: 328489340
• Report Number: 3005099803-2023-06045
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 08714729202011
• UDI-Public: 08714729202011
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• 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: 0030995031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2023
• 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