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	11/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
Note: this report pertains to one of two hurricane rx dilation balloons used during the same procedure.It was reported to boston scientific corporation that the two hurricane rx dilation balloons were used in the pancreaticobiliary during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the two balloons both had a small hole, causing contrast leakage in the bile duct.The physician decided to not dilate further, and the procedure was completed with a plastic stent.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was confirmed to be stable.
Event or Problem Description
Note: this report pertains to one of two hurricane rx dilation balloons used during the same procedure.It was reported to boston scientific corporation that the two hurricane rx dilation balloons were used in the pancreaticobiliary during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the two balloons both had a small hole, causing contrast leakage in the bile duct.The physician decided to not dilate further, and the procedure was completed with a plastic stent.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was confirmed to be stable.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: problem code 1504 captures the reportable event of balloon pinhole.Block h10: investigation results a visual examination of the returned complaint device found that the balloon and the catheter did not have any visual defects and was in a good condition.Functional evaluation could not be performed as the balloon lumen was blocked, and it was not possible to unclog it.The balloon was visually inspected through high magnification, and it was discovered that the balloon had a pinhole located at the proximal ro marker of the balloon.This failure is likely due to problems traced to design/design features of the device that do not support or interfere with the intended purpose of the device.Therefore, the most probable root cause is design inadequate for purpose.An investigation to address this issue has been completed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• 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: 9451866
• Report Number: 3005099803-2019-05850
• Device Sequence Number: 14228986
• Product Code: FGE
• UDI-Device Identifier: 08714729283805
• UDI-Public: 08714729283805
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 01/16/2020

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: 12/16/2020
• Device Model Number: M00545890
• Device Catalogue Number: 4589
• Device Lot Number: 0023196198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1