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

Model Number M00558360

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual examination of the complaint device revealed the distal tip of the balloon was bent.No damage was found on the catheter of the device.Functional analysis was performed, the balloon was able to be connected with an alliance inflation system.No issues were noted to the balloon material; no leaks were noted and the balloon was able to hold pressure.It was not possible to confirm what the customer alleged.Factors encountered during the procedure, such as the interaction between the device and the patient anatomy and/or the manner as the device was manipulated, could have caused the event reported by the customer and the analyzed failure of distal tip kinked.It is possible that the connections between the devices may not have been sufficiently tight to maintain the pressure between both devices during the procedure.However, it is not possible to confirm the complaint as the device passed all the functional analysis.Based on the analysis performed and the information provided, the most probable root cause for the complaint event is no problem detected since the reported device complaint or problem cannot be confirmed.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 an upper gi balloon dilation procedure performed in the esophagus on (b)(6) 2019.According to the complainant, during the procedure, the balloon and the alliance syringe would not connect together.Reportedly, the luer lock felt stripped and would continually rotate; it would not tighten down.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.Investigation results revealed the distal tip was bent; 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: 8861456
• MDR Text Key: 153427642
• Report Number: 3005099803-2019-03693
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 08714729195986
• UDI-Public: 08714729195986
• 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: Physician
• Type of Report: Initial
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2020
• Device Model Number: M00558360
• Device Catalogue Number: 5836
• Device Lot Number: 0021797827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 08/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2018
• 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