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

Model Number	80619
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip broke.The target lesion was located in the mildly tortuous and non calcified vessel.A direxion hi-flo was selected for use.During the middle of the procedure, it was noted that the tip stretched and was stripped.Upon removal, the device looked broken or kinked.It was noted by the physician that this same event had occurred in a previous procedure with the same device.The procedure was completed with a different device.No patient complications were reported.

• 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: 12452369
• Report Number: 2134265-2021-11117
• Device Sequence Number: 1180636
• Product Code: KRA
• UDI-Device Identifier: 08714729839484
• UDI-Public: 08714729839484
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2021

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: 07/22/2022
• Device Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0025751569
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1