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

Model Number	M00545890
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to a hurricane rx dilatation balloon and naviflex rx delivery system used in the same patient and procedure.It was reported to boston scientific corporation that a hurricane rx dilatation balloon and naviflex rx delivery system were attempted to be used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the rx tunnel (black segment or sheath) of the balloon detached inside the scope and a plastic stent got stuck inside the rx tunnel that detached.A photo of the device was provided by the customer and showed that the rx tunnel of the device was detached.The customer reported that the catheter broke and consequently reported that no pieces of the device detached inside the patient.The procedure was not completed due to this event and was reported to be rescheduled.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of balloon rx tunnel detachment.Imdrf device code a0401 captures the reportable event of catheter break.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of balloon rx tunnel detachment.Imdrf device code a0401 captures the reportable event of catheter break.Block h11: investigation results the returned hurricane rx dilatation balloon was analyzed, and a visual inspection found no damages or evidence of catheter break however, the device returned without the rx tunnel.A media inspection was performed on the photos provided by the customer and shows that the rx tunnel was detached.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon rx tunnel detachment was confirmed however, the reported event of catheter break was not confirmed.It is possible that the rx tunnel detached occurred due to procedural factors such as excess of force, pressure or anatomical conditions.Also, it is possible that interaction with a sharp surface during or previous to the procedure, could have caused the problem found.Therefore, the most probable root cause is an adverse event related to procedure.
Event or Problem Description
Note: this report pertains to a hurricane rx dilatation balloon and naviflex rx delivery system used in the same patient and procedure.It was reported to boston scientific corporation that a hurricane rx dilatation balloon and naviflex rx delivery system were attempted to be used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the rx tunnel (black segment or sheath) of the balloon detached inside the scope and a plastic stent got stuck inside the rx tunnel that detached.A photo of the device was provided by the customer and showed that the rx tunnel of the device was detached.The customer reported that the catheter broke and consequently reported that no pieces of the device detached inside the patient.The procedure was not completed due to this event and was reported to be rescheduled.There were no patient complications reported as a result of this event.

• Brand Name: HURRICANE RX
• Common Device Name: 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: 19355939
• Report Number: 3005099803-2024-02259
• Device Sequence Number: 6499989
• Product Code: FGE
• UDI-Device Identifier: 08714729283805
• UDI-Public: 08714729283805
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K001338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/13/2025
• Device Model Number: M00545890
• Device Catalogue Number: 4589
• Device Lot Number: 0031045361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown