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

Model Number M00545900

Device Problems Inflation Problem (1310); Material Integrity Problem (2978)

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

Event Date 06/19/2023

Event Type  malfunction  

Event Description

Attempted to dilate a biliary stricture.When the tech went to inflate the balloon, it popped on the first attempt.Device was removed from patient and new balloon dilation catheter used.

• Brand Name: HURRICANE RX BILIARY BALLOON DILATION CATHER
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 17324713
• MDR Text Key: 319027630
• Report Number: 17324713
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: M00545900
• Device Catalogue Number: M00545900
• Device Lot Number: 31099443
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/21/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA
• Patient Sex: Male