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

Model Number	80619
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that nickel shaft fracture occurred.A 027/straight/1ro/155 direxion hi-flo catheter infusion was selected for use.During the procedure, the microcatheter was implanted but couldn't be advanced and was discovered to be broken around 0.2cm from the hub.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Inspection of the device revealed nickel shaft fractures.Microscopic inspection of the device revealed multiple areas along the shaft with nickel shaft fractures.Media was returned in the form of a photo.The photo was reviewed which showed the device was fractured.Media review in conjunction with lab analysis was able to confirm the alleged complaint issue.
Event or Problem Description
It was reported that nickel shaft fracture occurred.A 027/straight/1ro/155 direxion hi-flo catheter infusion was selected for use.During the procedure, the microcatheter was implanted but couldn't be advanced and was discovered to be broken around 0.2cm from the hub.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported.

• Brand Name: DIREXION HI-FLO
• Common Device Name: 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: 19799203
• Report Number: 2124215-2024-44068
• Device Sequence Number: 8303119
• Product Code: KRA
• UDI-Device Identifier: 08714729839491
• UDI-Public: 08714729839491
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K142259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/09/2025
• Device Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0031025298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 71 KG