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 09/01/2023

Event Type  malfunction  

Event Description

Note: 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 balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.Prior to the procedure, the balloon burst.The second hurricane rx dilatation balloon used burst during the procedure.The customer stated that no pieces of the balloon 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 b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0402 captures the reportable event of balloon burst.

Event Description

Note: 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 balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.Prior to the procedure, the balloon burst.The second hurricane rx dilatation balloon used burst during the procedure.The customer stated that no pieces of the balloon 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 b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0402 captures the reportable event of balloon burst.Block h10: investigation results: the returned hurricane rx dilatation balloon 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 balloon (distal section) located approximately 8 mm from the tip.Microscopic inspection found a pinhole located approximately at 8 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 a balloon burst cannot be confirmed.The pinhole problem found could have been interpreted by the customer as the reported event of a balloon burst.The pinhole found is likely to have occurred due to procedural factors such as excess of pressure, interaction with other devices, or anatomical conditions.Also, it is possible that interaction with a sharp surface during/previous the procedure could have caused the problem found on the distal section of the balloon.Therefore, the most probable root cause is an adverse event related to procedure.

• 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: 17840370
• MDR Text Key: 324559271
• Report Number: 3005099803-2023-05130
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729283812
• UDI-Public: 08714729283812
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

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: 0031703129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2023
• 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