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 Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is an estimated date based off the aware date as the exact event date was not reported.
Event or Problem Description
It was reported that the catheter fell apart.A direxion hi-flo catheter was selected use.During the procedure, when the device was withdrawn, it was noted that the catheter fell apart.The procedure was completed with the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Date of event is an estimated date based off the aware date as the exact event date was not reported.Device evaluated by mfr.: returned product was a direxion catheter.The tip and inner/outer shaft were microscopically and visually inspected.Inspection revealed a complete separation in the outer shaft, and the inner shaft was kinked directly below the strain relief.The rest of the device was inspected, and no other damage or irregularities were found.
Event or Problem Description
It was reported that the catheter fell apart.A direxion hi-flo catheter was selected use.During the procedure, when the device was withdrawn, it was noted that the catheter fell apart.The procedure was completed with the same device.There were no patient complications reported.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: 8350288
• Report Number: 2134265-2019-01381
• Device Sequence Number: 14024456
• Product Code: KRA
• UDI-Device Identifier: 08714729839545
• UDI-Public: 08714729839545
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 08/20/2019

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: 22609318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1