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

Model Number	80618
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 06-dec-2022.It was reported that a fracture occurred.Two direxion catheters were selected for use.During the procedure, the catheters fractured a few centimeters from the hub on a portion of the device external to the patient.The procedure was cancelled due to unfavorable anatomy.There were no patient complications.However, device analysis revealed a fracture 32.7cm from the hub.
Additional Manufacturer Narrative
Device evaluated by mfr: the direxion microcatheter was returned to boston scientific for analysis.The device shaft was visually and microscopically analyzed for any damage.The shaft showed 2 fractures located 5cm and 32.7cm from the hub.The device was not completely separated as the inner liner was still attached.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

• Brand Name: DIREXION
• Common Device Name: 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: 16016083
• Report Number: 2134265-2022-08967
• Device Sequence Number: 20517775
• Product Code: KRA
• UDI-Device Identifier: 08714729839392
• UDI-Public: 08714729839392
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2022

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: 10/08/2023
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0028166664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2021
• 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