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

Model Number M00545920

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation result: visual examination of the returned complaint device revealed that the device was received inside of a plastic bag, the original pouch was not returned.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, the most probable root cause is cause not established.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

It was reported to boston scientific corporation that a hurricane rx dilation balloon was used during a bile duct dilation procedure performed on (b)(6) 2019.According to the complainant, during preparation, the inner package was found to be damaged after opening the outer package.The procedure was completed with another hurricane rx dilation balloon.There were no patient complications reported as a result of the event.The patient condition at the conclusion of the procedure was reported to be stable.

• Brand Name: HURRICANE RX
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road,; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8332313
• MDR Text Key: 135949764
• Report Number: 3005099803-2019-00517
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729283836
• UDI-Public: 08714729283836
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K001338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2019
• Device Model Number: M00545920
• Device Catalogue Number: 4592
• Device Lot Number: 0021614915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 70