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

Model Number	M00545890
Medical Device Problem Codes	Inflation Problem (1310); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
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 dilatation balloons were used in the common bile duct (cbd) and left hepatic duct during a dilation of hepatic duct procedure performed on (b)(6) 2021.During the procedure, inflation of the balloon was attempted; however, the balloon would not inflate.Reportedly, the device was taken out of the patient and was tested but inflation was still unsuccessful.The same problem occurred with the second, third and fourth hurricane rx dilatation balloons.The procedure was not able to be completed as it was cancelled by the physician and the patient was referred to radiology.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
• MDR Report Key: 12228410
• Report Number: 3005099803-2021-03715
• Device Sequence Number: 3509040
• Product Code: FGE
• UDI-Device Identifier: 08714729283805
• UDI-Public: 08714729283805
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/26/2021

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: 10/17/2022
• Device Model Number: M00545890
• Device Catalogue Number: 4589
• Device Lot Number: 0026366746
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1