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

Model Number 80619

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 11/22/2022

Event Type  malfunction  

Event Description

It was reported that the catheter split in half.A direxion infusion catheter was selected for use in an embolization procedure.The catheter was introduced into the patient.However, it was noted that the catheter appeared damaged.It was removed, and upon inspection, it was found kinked and split in half.A new direxion infusion catheter was used to complete the procedure.There were no patient complications.

Event Description

It was reported that the catheter split in half.A direxion hi-flo infusion catheter was selected for use in an embolization procedure.The catheter was introduced into the patient.However, it was noted that the catheter appeared damaged.It was removed, and upon inspection, it was found kinked and split in half.A new direxion hi-flo was used to complete the procedure.There were no patient complications.

Manufacturer Narrative

Device eval by mfr: the direxion microcatheter was returned for analysis.The device shaft was visually and microscopically analyzed for any damage.The devices shaft showed a fracture located 8.8cm from the hub.The device was not completely separated the inner liner was still attached.No kinks were noticed.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

• Brand Name: DIREXION HI-FLO
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15993157
• MDR Text Key: 307931157
• Report Number: 2124215-2022-50572
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729839484
• UDI-Public: 08714729839484
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K142259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2023
• Device Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0028436531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2021
• 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