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

Model Number	M00545960
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a0401 captures the reportable event of catheter break.
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was used in the biliary ducts during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the catheter tore from the balloon while pulling out the device.The procedure was completed with another hurricane rx dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code (b)(6) captures the reportable event of catheter break.The returned hurricane rx dilatation balloon was analyzed and a visual examination found that the catheter detached near to the proximal balloon bond.No damages were found to the balloon.Microscopic inspection of the catheter confirmed that it was detached near to the proximal balloon bond.Electron microscopy found that the top surface presented features of torsion mechanism, as polymer tearing fibers and polymer elongation produced by mechanical overload.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of catheter break was confirmed as the catheter was detached on the returned device.It is possible that the factors are due to the manner the device was handled and manipulated.Excessive manipulation of the device without enough care could have induced the problem found.The catheter was detached near to the proximal balloon bond on the returned device.Based on the evidence, the catheter detached found in the device is likely to have occurred due the manner as the device was handled and manipulated may have caused the reported and encountered failure.Electron microscopy analysis performed observed the reduction on the diameter and the features as plastic deformation, polymer tearing fibers and polymer elongation, suggesting, torsion overload mechanism and possible elongation.These factors and interactions could influence the damage found in the returned device.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 instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was used in the biliary ducts during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the catheter tore from the balloon while pulling out the device.The procedure was completed with another hurricane rx dilatation balloon.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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16464505
• Report Number: 3005099803-2023-01057
• Device Sequence Number: 7774769
• Product Code: FGE
• UDI-Device Identifier: 08714729283874
• UDI-Public: 08714729283874
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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: 0029767013
• 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: 02/08/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 06/07/2023
• 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 Sex: Unknown