MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION HI-FLO TRANSEND-18 SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number	84593
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A direxion hi-flo transend-18 system catheter-infusion was selected for use.During the procedure, an idc-18 coil was successfully deployed.A second non-bsc coil was selected.However, during advancement, resistance was encountered.It was unable to pull back or deploy the coil.Upon removal, the catheter outer tube was found broken.The inner lining was intact, the catheter was withdrawn in one piece.The procedure was completed with a different device.No complications were reported, and the patient was stable.
Event or Problem Description
It was reported that shaft break occurred.A direxion hi-flo transend-18 system catheter-infusion was selected for use.During the procedure, an idc-18 coil was successfully deployed.A second non-bsc coil was selected.However, during advancement, resistance was encountered.It was unable to pull back or deploy the coil.Upon removal, the catheter outer tube was found broken.The inner lining was intact, the catheter was withdrawn in one piece.The procedure was completed with a different device.No complications were reported, and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the direxion hi-flo microcatheter was returned for analysis.Visual examination revealed that the catheter shaft showed a nickel shaft fracture.Media inspection of the photo was reviewed which showed the device was fractured.

• Brand Name: DIREXION HI-FLO TRANSEND-18 SYSTEM
• 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: 18997054
• Report Number: 2124215-2024-16222
• Device Sequence Number: 2969532
• Product Code: KRA
• UDI-Device Identifier: 08714729839842
• UDI-Public: 08714729839842
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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): 04/29/2024

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: 05/12/2024
• Device Model Number: 84593
• Device Catalogue Number: 84593
• Device Lot Number: 0029394194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2022
• 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 Sex: Unknown