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

Model Number M00545920

Device Problems Leak/Splash (1354); Appropriate Term/Code Not Available (3191)

Patient Problem Swelling/ Edema (4577)

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation result: a visual examination of the returned complaint device found that the balloon and the catheter of device had no damages.Microscopic analysis was performed, it was noticed that the balloon had a pinhole, which confirms the reported event of balloon leaked.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 (b)(6) 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 device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu) product label.

Event Description

Note: this report pertains to one of two hurricane rx dilatation balloons used in the same patient and procedure.It was reported to boston scientific corporation that two hurricane rx dilatation balloons were used in the biliary tree during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, it was noticed that the balloon had a pinhole leak.A second hurricane rx dilatation balloon was used and they were able to dilate the second stricture; however, it was noticed that there were bubbles coming out at the ampulla.The device was removed and balloon sweep was performed.The procedure was not completed due to this event.The physician noted that there was submucosal swelling.There were no patient complications reported as a result of this event.

• 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: 12497462
• MDR Text Key: 272489210
• Report Number: 3005099803-2021-04820
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729283836
• UDI-Public: 08714729283836
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001338
• 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: 09/20/2021

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: 03/31/2023
• Device Model Number: M00545920
• Device Catalogue Number: 4592
• Device Lot Number: 0027065830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2021
• 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