MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HURRICANE RX; CATHETER, BILIARY, DIAGNOSTIC

Model Number M00545900

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)

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

Event Date 11/08/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results: a visual and microscopic examination of the returned complaint device found that the balloon ruptured, which confirms the reported event of balloon leaked.No damage was found on the catheter of the device.Based on the available information, it is possible that interaction with any surface during the procedure could create friction on the balloon, causing the problem of ruptured during the procedure.Therefore, the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.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 hurricane rx dilatation balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, it was noted that when the balloon swells, water leaks out.The procedure was completed with another hurricane rx dilation balloon.There were no patient complications reported as a result of this event.This event has been deemed reportable based on the investigation results of balloon burst.

• Brand Name: HURRICANE RX
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• 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: 13362239
• MDR Text Key: 284803003
• Report Number: 3005099803-2022-00175
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729283812
• UDI-Public: 08714729283812
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K001338
• 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: 01/26/2022

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: 12/27/2022
• Device Model Number: M00545900
• Device Catalogue Number: 4590
• Device Lot Number: 0026699191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2021
• 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