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

Model Number	80619
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was difficult to remove.A direxion hi-flo catheter was selected for use in a uterine fibroid embolization procedure.During the procedure, it was noted that the catheter was difficult to remove from the patient and the guidewire used also became bent.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that the device was difficult to remove.A direxion hi-flo catheter was selected for use in a uterine fibroid embolization procedure.During the procedure, it was noted that the catheter was difficult to remove from the patient and the guidewire used also became bent.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device shaft was analyzed for any damage.The devices shaft showed damage 2cm and 3cm from the tip.A.014 test guidewire was inserted into the device.The guidewire would not transcend through the lumen.The device was occluded.The device was soaked for a period of 24hrs and retested by inserting the guidewire.The guidewire did transcend through the lumen and it was noticed that blood and possibly contrast was in the device.The direxion od was measured on a laser micrometer and measure.0382 diameter which is in the specification.The device was then inserted into a terumo test guide catheter (.041id) and the device transcended through the device; however, removal was difficult.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: 8925470
• Report Number: 2134265-2019-10176
• Device Sequence Number: 18892809
• Product Code: KRA
• UDI-Device Identifier: 08714729839521
• UDI-Public: 08714729839521
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/23/2020

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: 04/21/2021
• Device Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0023673507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 06/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BSC FATHOM WIRE; BSC FATHOM WIRE; COOK BEACON TIP RPT G57017; COOK BEACON TIP RPT G57017; BSC FATHOM WIRE; COOK BEACON TIP RPT G57017