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

Model Number	80619
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event date of (b)(6) 2020 is an estimate date based of the aware date of 08jun2020 as the exact event date was not reported.Device evaluated by manufacturer.The device was returned for analysis.Returned product consisted of a direxion hi flo microcatheter inside a cook 5f guide catheter.The devices were bloody, and they could not be separated during analysis.Analysis of the tip and inner/outer shaft included microscopic and visual inspection.Inspection revealed a complete separation in the outer shaft located 65.1cm from the strain relief, with the inner shaft stretched, flattened and had numerous kinks in between the outer shaft fracture faces.Inspection of the rest of the device found no other damage or defects.Because the device could not be separated, the outer diameter (od) of the undamaged direxion shaft was measured via a calibrated microcatheter.The undamaged shaft measured 037, which meets the specification.Review of the ifu indicates the direxion hi-flo is compatible with a.038 5f guide catheter.The reported information indicates the direxion hi-flo catheter was used with a.035 5f cook guide catheter; therefore, there is indication of a compatibility issue.
Event or Problem Description
Reportable based on device analysis completed on 27jul2020.It was reported that device got stuck.A single/027/straight/1ro/155 direxion hi-flo catheter-infusion was selected for a uterine fibroid embolization procedure.During the procedure, the direxion's microcatheter was stuck inside a non-bsc urinary catheter.Both catheters were pulled out.No complications reported.However, device analysis revealed a complete separation in the outer shaft located 65.1cm from the strain relief.

• 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: 10379160
• Report Number: 2134265-2020-10623
• Device Sequence Number: 1712351
• Product Code: KRA
• UDI-Device Identifier: 08714729839491
• UDI-Public: 08714729839491
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2020

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: 11/27/2021
• Device Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0024845425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1