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

Model Number	80619
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device shaft was analyzed for any damage.The devices shaft showed 3 fractures located 3.5cm, 81.5cm and 82cm from the hub.The shaft was not completely separated the inner liner was still connected.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
Reportable based on device analysis completed on 15dec2020.It was reported that hub break occurred.The target lesion was located in the moderately tortuous uterine artery.A direxion hi-flo was selected for use.The device was hydrated prior to removal from the hoop.Towards the end of the embolization administration, it was noted that the hub broke.The procedure was completed with another of same device.No patient complications were reported.However, device analysis revealed a shaft fractures at 81.5cm and 82cm from the hub.

• Brand Name: DIREXION HI-FLO
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11038245
• Report Number: 2134265-2020-18195
• Device Sequence Number: 1265775
• Product Code: KRA
• UDI-Device Identifier: 08714729839521
• UDI-Public: 08714729839521
• Combination Product (Y/N): N
• Initial Reporter State: CO
• PMA/510(K) Number: K142259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2020

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: 02/25/2022
• Device Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0025270593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1