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

Model Number M00545900

Device Problems Burst Container or Vessel (1074); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/15/2023

Event Type  malfunction  

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 distal common hepatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2023.During the procedure, it was noted that the first balloon burst at 12 psi after being advanced through the duodenoscope into the common hepatic duct and inflate.Additionally, the same problem occurred on the second hurricane rx dilatation balloon which also burst at 11 psi.The customer stated that no pieces of the balloons detached inside the patient.The procedure was completed with a third hurricane rx dilatation balloon.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a0402 captures the reportable event of balloon burst.

Manufacturer Narrative

Block h6: imdrf device code a0402 captures the reportable event of balloon burst.Block h10: investigation results the returned hurricane rx dilatation balloons was analyzed, and a visual examination found that the balloon and catheter of the device had no damages.Functional analysis was performed, and the balloon was inflated without a problem.However, the balloon would not hold pressure due to a pinhole in the distal section approximately 9mm from the tip of the balloon.Microscopic inspection found the balloon had a pinhole located approximately 9 mm from the tip of the device.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon burst was not confirmed.The pinholes found in the balloon are likely to have occurred due to factors encountered during the procedure: excess pressure, interaction with other devices, or patient anatomy.It is possible that factors encountered during the procedure, such as the interaction with any kind of sharp surface could create friction on the balloon and cause physical damage.Therefore, the most probable root cause is adverse event related to procedure.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/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 distal common hepatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6)2023.During the procedure, it was noted that the first balloon burst at 12 psi after being advanced through the duodenoscope into the common hepatic duct and inflate.Additionally, the same problem occurred on the second hurricane rx dilatation balloon which also burst at 11 psi.The customer stated that no pieces of the balloons detached inside the patient.The procedure was completed with a third hurricane rx dilatation balloon.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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17686158
• MDR Text Key: 322675217
• Report Number: 3005099803-2023-04711
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729283812
• UDI-Public: 08714729283812
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

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 Model Number: M00545900
• Device Catalogue Number: 4590
• Device Lot Number: 0030145484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 10/10/2023
• Supplement Dates FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2022
• 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