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

Model Number	M00545960
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was used in the papilla of vater during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During withdrawal, after the balloon was deflated, the tip of the catheter tore behind the distal balloon end and detached inside the patient.The detached piece was retrieved using forceps.The procedure was already completed with the original device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of tip detached.Investigation code c070601 captures the reportable investigation result of balloon detached.Block h10: investigation result the returned hurricane rx dilatation balloon was analyzed and a visual examination found that the balloon was detached and a kink was found on the catheter next to the balloon.There was no damage found on the tip of the device.Microscopic evaluation of the device revealed that the balloon was detached and the catheter had irregular edges in the detachment area.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of tip detachment could not be confirmed as no damages were found to the tip of the returned device.However, it was found that the catheter was kinked next to the balloon and the balloon was detached.This physical damage is likely due to the manipulation of the catheter during the procedure.Forcing the device against significant resistance or interaction with the elevator of the scope could result in device damage or loss of functionality.It is likely that the kink in the catheter could have caused difficulties during the removal of the device, leading to the detachment of the balloon.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 papilla of vater during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During withdrawal, after the balloon was deflated, the tip of the catheter tore behind the distal balloon end and detached inside the patient.The detached piece was retrieved using forceps.The procedure was already completed with the original device.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: 15807134
• Report Number: 3005099803-2022-06707
• Device Sequence Number: 5616386
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2024
• Device Model Number: M00545960
• Device Catalogue Number: 4596
• Device Lot Number: 0029952050
• 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: 10/26/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown