MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION; CATHETER, CONTINUOUS FLUSH

Model Number 80618

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978); Poor Visibility (4072)

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

Event Date 02/27/2024

Event Type  Injury  

Event Description

It was reported that a device fracture occurred requiring snare for removal.A direxion microcatheter was selected for abdominal embolization.During coil deployment, it was noted that a tiny piece of microcatheter broke inside the patient's body.The broken piece was very hard to visualize under fluoroscopy.The detached portion of the device was removed by snare.No patient complications were reported.

• Brand Name: DIREXION
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18933292
• MDR Text Key: 338026742
• Report Number: 2124215-2024-13690
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729839323
• UDI-Public: 08714729839323
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0032751517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2023
• 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
• Patient Outcome(s): Required Intervention