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

Model Number	M00545960
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During preparation, the balloon was noted to be damaged and could not be opened.The procedure was completed with another hurricane rx dilatation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.Note: 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 event occurred outside of the patient.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) medical university.Block h6: imdrf code a04 captures the reportable event of balloon damaged.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).Block h6: imdrf code a04 captures the reportable event of balloon damaged.
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During preparation, the balloon was noted to be damaged and could not be opened.The procedure was completed with another hurricane rx dilatation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.Note: 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 event occurred outside of the patient.Additional information was received on (b)(6) 2023.It was reported that the problem was noticed inside the patients body during the procedure.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).Block h6: imdrf code a04 captures the reportable event of balloon damaged.Block h10: investigation results the returned hurricane rx dilatation balloon was analyzed, and a visual examination found that the catheter was partially detached near the proximal balloon bond.No damages were found to the balloon.A functional inspection was performed, and the device was connected to an alliance inflation system.However, the balloon did not hold pressure due to a leak in the catheter.Microscopic inspection of the catheter confirmed that it was partially detached near the proximal balloon bond.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon damaged/defective was confirmed as the catheter was partially detached on the returned device.It is possible that the lesion characteristics, handling of the device, or the technique used by the physician (force applied), could have resulted in the damages encountered in the device.Excessive manipulation of the device without enough care could have induced the defect found.Based on the available information, the catheter detachment is likely to have occurred due the manner in which the device was handled and manipulated.Therefore, the most probable root cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During preparation, the balloon was noted to be damaged and could not be opened.The procedure was completed with another hurricane rx dilatation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.Note: 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 event occurred outside of the patient.Additional information was received on may 16, 2023: it was reported that the problem was noticed inside the patients body during the procedure.

• 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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16942921
• Report Number: 3005099803-2023-02552
• Device Sequence Number: 11598023
• Product Code: FGE
• UDI-Device Identifier: 08714729283874
• UDI-Public: 08714729283874
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2024
• Device Model Number: M00545960
• Device Catalogue Number: 4596
• Device Lot Number: 0029767014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/23/2023
• Supplement Date Received by Manufacturer: 05/16/2023; 08/04/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 06/08/2023; 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2022
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Weight: 64 KG