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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported nitinol coating came off.The target lesion was located in a vessel in the uterus area.A 155cm direxion hi-flo was selected for use.During the procedure, it was noted that the nitinol coating came off at about 20cm from proximal yellow hub.Subsequently, the physician lost all tracking but was able to complete the procedure with the device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device was inspected for any damage or irregularities.The direxion had a fracture 1 mm from the strain relief and kinks 10.6 cm and 106.4 cm from the strain relief.The strain relief was not removed from the hub due to the location of the fracture.The shaft was not completely separated, the inner liner was still intact.The fracture looked consistent with a bending and tensile force breaking.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
Event or Problem Description
It was reported nitinol coating came off.The target lesion was located in a vessel in the uterus area.A 155cm direxion hi-flo was selected for use.During the procedure, it was noted that the nitinol coating came off at about 20cm from proximal yellow hub.Subsequently, the physician lost all tracking but was able to complete the procedure with the 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14168701
• Report Number: 2134265-2022-04221
• Device Sequence Number: 6028484
• Product Code: KRA
• UDI-Device Identifier: 08714729839491
• UDI-Public: 08714729839491
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2022

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: 01/27/2024
• Device Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0028756877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2022
• Supplement Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown