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

Model Number	M00545890
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation result: visual examination of the returned complaint device found that the balloon and the catheter of the device had no damages.Microscopic inspection found that the balloon had a pinhole.Functional analysis cannot be performed due to the balloon lumen being occluded and could not be unblocked, likely due to dry contrast.It is possible that interaction with scope and other devices during procedure could create friction on the balloon, causing the balloon pinhole during the procedure.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.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
Note: this report pertains to one of four hurricane rx dilatation balloons used in the same patient and procedure.It was reported to boston scientific corporation that four hurricane rx dilation balloons were used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, it was noted that the balloons were leaking.The procedure was completed with another hurricane rx dilation balloon.There were no patient complications reported as a result of this event.Investigation results revealed that the balloon had a pinhole; therefore, this is now an mdr reportable event.

• Brand Name: HURRICANE RX
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11380623
• Report Number: 3005099803-2021-00688
• Device Sequence Number: 17108537
• Product Code: FGE
• UDI-Device Identifier: 08714729283805
• UDI-Public: 08714729283805
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2021

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: 10/28/2022
• Device Model Number: M00545890
• Device Catalogue Number: 4589
• Device Lot Number: 0026429808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1