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	01/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: a visual examination of the returned complaint device found that the balloon did not have any visual defects and was in a good condition.The catheter of the device was carefully inspected and no damages were found.Functional evaluation was performed and the balloon was inflated without problem; however, the balloon would not hold pressure due to a pinhole in the proximal section on the body of the balloon.This failure is likely due to factors or conditions related to procedure during the use of the device, such as the manner in which the device was handled, the technique used by the physician during the procedure, and/or the interaction between the scope and device, that could have affected its performance and its intended purpose.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.
Event or Problem Description
It was reported to boston scientific corporation that a hurricane rx dilatation balloon was used during an endoscopic retrograde cholangiopancreatography (ercp) with dilatation procedure performed in the common bile duct (cbd) on (b)(6) 2020.According to the complainant, during the procedure, while inflating, a leak was noticed on the proximal edge of the balloon.The procedure was completed with another hurricane rx dilatation 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: 10009727
• Report Number: 3005099803-2020-01677
• Device Sequence Number: 2897696
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2020

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: 08/24/2021
• Device Model Number: M00545890
• Device Catalogue Number: 4589
• Device Lot Number: 0024482393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR