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

Model Number	80618
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the outer shaft ruptured.A direxion microcatheter was selected for use in an embolization procedure.During the procedure, a loop formed, and the outer shaft ruptured in the middle of the catheter, outside the patient.The device was removed from the patient intact.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: the direxion microcatheter was returned to boston scientific for analysis.The device shaft was analyzed for any damage.The shaft was fractured in two locations: 17.7cm and 62cm from the hub.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Fractures were confirmed.
Event or Problem Description
It was reported that the outer shaft ruptured.A direxion microcatheter was selected for use in an embolization procedure.During the procedure, a loop formed, and the outer shaft ruptured in the middle of the catheter, outside the patient.The device was removed from the patient intact.The procedure was completed with another of the same device.No patient complications were reported.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12215048
• Report Number: 2134265-2021-09394
• Device Sequence Number: 19908839
• Product Code: KRA
• UDI-Device Identifier: 08714729839354
• UDI-Public: 08714729839354
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2021

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: 05/19/2023
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0027340086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown