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

Model Number M00545900

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

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

Event Date 05/13/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual examination of the returned complaint device found that the catheter was kinked and the balloon had no damages.Microscopic analysis was performed, and it was noticed that the balloon had a two pinholes.During the microscope inspection the balloon was dissected to inspect the ro markers (distal-proximal) and no defects were noted.Functional evaluation was performed and the balloon was inflated without problem; however, the balloon would not hold pressure due to the pinholes located at the proximal section on the body of the balloon.Dimensional examination of the outer diameter (od) of the ro markers was performed and was measured in three sections; distal, medium, and proximal.The three sections were within specification.The most probable cause of the event was caused traced to device design.The balloon pinhole was likely caused by the radiopaque (ro) marker on the device during use.When the hurricane rx biliary balloon dilatation catheter device is used at high elevator angles (>70 degrees, which is a range of angles infrequently used to reach the desired target location), interaction between the device and the scope can contribute to balloon pinholes due to ro marker contact with the balloon.In june 2021, a corrective action was implemented to reduce the potential for similar balloon pinhole events.The corrective action included applying glue around both edges of the ro markers during manufacturing, which adds a protective layer around the ro marker and reduces the potential for balloon pinholes during use.The referenced device was manufactured prior to implementation of this solution.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 biliary tree during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the balloon could not be inflated and was noted to be leaking.The procedure was completed with another hurricane rx 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 balloon pinhole.

• 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: 12315822
• MDR Text Key: 266304826
• Report Number: 3005099803-2021-04055
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729283812
• UDI-Public: 08714729283812
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K001338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/12/2021

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: 02/25/2023
• Device Model Number: M00545900
• Device Catalogue Number: 4590
• Device Lot Number: 0026872356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2021
• 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