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 06/01/2021

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).Investigation result: a visual examination of the returned complaint device found that the balloon and catheter have no damages.Microscopic analysis was performed, and it was noticed that the balloon had a pinhole, which confirms the reported event of balloon leak.During the microscope inspection the balloon was dissected to inspect the ro markers (distal-proximal) and no defects were noted.Functional analysis could not be performed due to the balloon lumen being occluded by dry contrast, and the occlusion could not be unblocked; this occlusion is normal due to the use of contrast during the procedure.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

This report pertains to one of two hurricane rx dilatation balloons used during the same procedure.It was reported to boston scientific corporation that two hurricane rx dilatation balloons were used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, the balloon was noted to be leaking contrast.The same issue occurred with the second hurricane rx dilatation balloon.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 CORPORATION; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12333328
• MDR Text Key: 266958905
• Report Number: 3005099803-2021-04152
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729283812
• UDI-Public: 08714729283812
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 08/17/2021

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: 03/24/2023
• Device Model Number: M00545900
• Device Catalogue Number: 4590
• Device Lot Number: 0027027296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2021
• 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