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

Model Number	M00545910
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the balloon was leaking and had a blatant hole.The same issue occurred with the second hurricane rx dilation balloon.A photo sent by the customer showed that the balloon leaked due to a pinhole at the proximal end.Reportedly, the physician pulled out the device and the procedure was completed with a cre rx dilatation balloon.There were no patient complications reported as a result of this event.
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 duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the balloon was leaking and had a blatant hole.The same issue occurred with the second hurricane rx dilation balloon.A photo sent by the customer showed that the balloon leaked due to a pinhole at the proximal end.Reportedly, the physician pulled out the device and the procedure was completed with a cre rx dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Problem code 1504 captures the reportable issue of balloon pinhole.A visual examination of the complaint device revealed that the device did not have any visual defects.Functional analysis was performed, and the balloon was inflated without problem; however, the balloon would not hold pressure due to pinholes found on the balloon in both ro markers at the proximal and distal bonds of the balloon.This failure is likely due to an expected or random component failure without any design or manufacturing issue.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.

• 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: 7853595
• Report Number: 3005099803-2018-60299
• Device Sequence Number: 11045282
• Product Code: FGE
• UDI-Device Identifier: 08714729283829
• UDI-Public: 08714729283829
• 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,Followup
• Report Date (Section B): 10/16/2018

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: 01/22/2020
• Device Model Number: M00545910
• Device Catalogue Number: 49875
• Device Lot Number: 0021770059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1