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

Model Number	80619
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a direction hi flo microcatheter.There was contrast in the device.Analysis of the tip, inner/outer shaft and strain relief/hub included microscopic and visual inspection.Inspection revealed shaft damage (inner stretched/outer shaft fractured) located 24.2cm from the strain relief.Inspection of the rest of the device found no other damage or defect.
Event or Problem Description
Reportable based on device analysis completed on 07jan2020.It was reported that catheter was bent.The target lesion area was located in the pelvic area.A direxion hi-flo was selected for use.During the procedure, it was noted that the catheter got bent.The device was pulled out from the patient's body.The procedure was completed with a different device.No complications were reported and the patient's condition was fine post procedure.However, device analysis revealed the shaft was fractured.

• 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: 9610668
• Report Number: 2134265-2020-00289
• Device Sequence Number: 547085
• Product Code: KRA
• UDI-Device Identifier: 08714729839521
• UDI-Public: 08714729839521
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2020

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 Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0024164444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1