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

Model Number	M001195440
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The hub of the micro-catheter cracked.It broke off outside the patient, and the physician used another micro-catheter.There was no harm to the patient.

• 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: 7705897
• Report Number: 7705897
• Device Sequence Number: 600532
• Product Code: KRA
• UDI-Device Identifier: 08714729839514
• UDI-Public: (01)08714729839514(17)200125(10)21658357
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/17/2018
• Report Date (Section F): 07/17/2018

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 Model Number: M001195440
• Device Lot Number: 21658357
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 07/20/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 56
• Date Report Sent to FDA: 07/17/2018