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

Model Number M001195440

Device Problems Break (1069); Crack (1135); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2018

Event Type  malfunction  

Event 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
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7705897
• MDR Text Key: 114600134
• Report Number: 7705897
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729839514
• UDI-Public: (01)08714729839514(17)200125(10)21658357
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M001195440
• Device Lot Number: 21658357
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2018
• Event Location: Other
• Date Report to Manufacturer: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29930 DA
• Patient Weight: 56