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

Model Number	M00545960
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device code (b)(4).The complainant indicated that the device has been disposed and is not available for return; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
Note: this report pertains to one of two hurricane rx dilatation balloons used during the same procedure.It was reported to boston scientific corporation that two hurricane rx dilatation balloon were used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2021.During the procedure, it was noted that both balloons popped.The procedure was completed with a hurricane rx balloon of a different size.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: 12488562
• Report Number: 3005099803-2021-04763
• Device Sequence Number: 19670594
• Product Code: FGE
• UDI-Device Identifier: 08714729283874
• UDI-Public: 08714729283874
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/17/2021

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: 06/15/2023
• Device Model Number: M00545960
• Device Catalogue Number: 4596
• Device Lot Number: 0027494090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1