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

Model Number	80619
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter became detached.A direxion hi flo infusion catheter was selected for use in a transarterial chemoembolization procedure in the left hepatic artery.After vascular access was gained, the catheter was placed into position and the guidewire was removed.The physician attempted to inject contrast but was unable.It was then observed that the catheter had detached from the hub.The catheter was also kinked which obstructed the inner lumen.The device was removed and replaced with a non-bsc device.The patient experienced increased radiation.The procedure was completed and no adverse patient effects occurred.
Additional Manufacturer Narrative
Device analysis by mfr: the returned product consisted of a direxion hi flo microcatheter.Inspection revealed the outer shaft had fractured 1 mm from the strain relief, and the inner shaft was stretched and bent.When the device was not under the microscope and was visually inspected, the damaged shaft area appeared to be a kink.Inspection of the rest of the device found no other damage or defect.
Event or Problem Description
It was reported that the catheter became detached.A direxion hi flo infusion catheter was selected for use in a transarterial chemoembolization procedure in the left hepatic artery.After vascular access was gained, the catheter was placed into position and the guidewire was removed.The physician attempted to inject contrast but was unable.It was then observed that the catheter had detached from the hub.The catheter was also kinked which obstructed the inner lumen.The device was removed and replaced with a non-bsc device.The patient experienced increased radiation.The procedure was completed and no adverse patient effects occurred.

• 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: 9588167
• Report Number: 2134265-2019-16786
• Device Sequence Number: 11368463
• Product Code: KRA
• UDI-Device Identifier: 08714729839514
• UDI-Public: 08714729839514
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2020

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: 11/28/2020
• Device Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0023004394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1