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 Consequences Or Impact To Patient (2199)
Date of Event	08/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the shaft broke.The target lesion was located in the severely tortuous mesenterica superior.A direxion microcatheter was used for an embolization procedure.During the procedure, it was noted that the nitinol shaft of the microcatheter broke inside the patient.The procedure was completed with this device and the device was removed.No patient complications were reported and the patient's condition was good.Device eval by manufacturer: returned product consisted of a direxion microcatheter.The shaft was microscopically examined.The device showed damage in the form of a separated shaft in 2 locations.The 1st location was 43cm from the hub and the 2nd location was 44.2cm from the hub.The shaft showed some slight bends from the tip proximally 12cm.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
• MDR Report Key: 7914980
• Report Number: 2134265-2018-61339
• Device Sequence Number: 11141395
• Product Code: KRA
• UDI-Device Identifier: 08714729839453
• UDI-Public: 08714729839453
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K142259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2018

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: 11/10/2019
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0021369157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1