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 Patient Involvement (2645)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the distal tip broke.A direxion hi-flo infusion catheter was selected for use.During preparation the distal tip of the catheter broke, the device was exchanged with another direxion hi-flo infusion catheter, there was no patient involvement.
Additional Manufacturer Narrative
Device was returned for analysis.The device shaft was analyzed for any damage.The devices shaft showed damage in the form of a fracture/separation located 4.2cm from the hub.The device was completely fractured/separated.The fractured/separated ends looked to be 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.A fracture/separation was confirmed.
Event or Problem Description
It was reported that the distal tip broke.A direxion hi-flo infusion catheter was selected for use.During preparation the distal tip of the catheter broke, the device was exchanged with another direxion hi-flo infusion catheter, there was no patient involvement.

• 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: 8767697
• Report Number: 2134265-2019-07883
• Device Sequence Number: 1832607
• Product Code: KRA
• UDI-Device Identifier: 08714729839521
• UDI-Public: 08714729839521
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K142259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

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: 09/04/2020
• Device Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0022609315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 07/08/2019
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1