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

Model Number	M00545890
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: a visual examination of the returned complaint device did not show visual defects.A functional examination was performed, the balloon was inflated and a leak was found due to a pinhole located in the body of the balloon near the proximal ro marker.This failure is likely due to adverse factors and/or conditions related to the procedure during the use of the device which limited the performance of the device.Therefore, the most probable root cause is cause traced to component failure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilation balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) performed on (b)(6) 2018.According to the complainant, during the procedure, the balloon had a hole, and 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 found 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: 8109979
• Report Number: 3005099803-2018-61654
• Device Sequence Number: 16577391
• Product Code: FGE
• UDI-Device Identifier: 08714729283805
• UDI-Public: 08714729283805
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K001338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/28/2018

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: 07/16/2020
• Device Model Number: M00545890
• Device Catalogue Number: 4589
• Device Lot Number: 0022521258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1