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

Model Number M00545900

Device Problems Burst Container or Vessel (1074); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/13/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to boston scientific corporation that a hurricane rx dilatation balloon was being prepared for use in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.Prior to the procedure, the balloon broke.The procedure was completed successfully.There were no patient complications reported as a result of this event.Note: no further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h11 (correction): block b5 (describe event or problem) and block h6 (device codes) have been updated.

Event Description

It was reported to boston scientific corporation that a hurricane rx dilatation balloon was being prepared for use in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.Prior to the procedure, the balloon broke.The procedure was completed successfully.There were no patient complications reported as a result of this event.Note: no further information has been obtained despite good faith efforts.Correction noted on january 3 ,2024.The instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.

Event Description

It was reported to boston scientific corporation that a hurricane rx dilatation balloon was being prepared for use in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.Prior to the procedure, the balloon broke.The procedure was completed successfully.There were no patient complications reported as a result of this event.Note: no further information has been obtained despite good faith efforts.Correction noted on january 3 ,2024: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.

Manufacturer Narrative

Block h6: imdrf device code a0402 captures the reportable event of a 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 not capable of being inflated due to it was occluded most likely with dry contrast media.Microscopic inspection found no damages on the balloon.The balloon has dry contrast media inside.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 results of the analysis performed on the returned device found that the device had some dry contrast media inside the catheter, restricting the capability of the device to have its functionality tested.Therefore, the most probable root cause is cause not established.A labeling review was performed, and from the information available, this device was not used per the instructions for use (ifu)/product label.

• 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: 18428639
• MDR Text Key: 331909784
• Report Number: 3005099803-2023-06960
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729283812
• UDI-Public: 08714729283812
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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,Followup
• Report Date: 03/08/2024

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: 0032680772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 01/03/2024; 02/19/2024
• Supplement Dates FDA Received: 01/24/2024; 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2023
• 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