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

Model Number M00545940

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a hurricane rx dilatation balloon was received by the customer on (b)(6), 2023.During unpacking, it was observed that there were damages on the bag of the device.A photo of the device packaging was provided by the customer and shows that the sterile pouch of the device packaging was damaged.The product was not used in a procedure.There were no patient complications have been reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a020503 captures the reportable event of seal compromised.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18386980
• MDR Text Key: 331381838
• Report Number: 3005099803-2023-06850
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729283850
• UDI-Public: 08714729283850
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K001338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00545940
• Device Catalogue Number: 4594
• Device Lot Number: 0032238270
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2023
• 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