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	08/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the catheter was broken.The target lesion was located in the liver.A direxion hi-flo catheter infusion was selected for use.During the procedure, it was noted that the catheter was broken.The procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that the catheter was broken.The target lesion was located in the liver.A direxion hi-flo catheter infusion was selected for use.During the procedure, it was noted that the catheter was broken.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.Device evaluated by manufacturer: the device was returned for analysis.The device was inspected for any damage or irregularities.The direxion showed damage in the form of a fracture located 73.8 from the hub.The shaft was not completely separated, the inner liner was still intact.A bend of the shaft was seen 125 cm from the hub.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• 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: 12019121
• Report Number: 2134265-2021-07536
• Device Sequence Number: 14309064
• Product Code: KRA
• UDI-Device Identifier: 08714729839484
• UDI-Public: 08714729839484
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 07/12/2021

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: 09/30/2022
• Device Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0026103595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR