MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION HI-FLO FATHOM-16 SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number	84591
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: returned device consisted of a direxion microcatheter in two pieces.Analysis of the tip, inner/outer shaft, and hub/strain relief included microscopic and visual inspection.Inspection revealed an outer shaft separation located 12mm from the tip of the device with the inner shaft stretched between the separation.Inspection of the rest of the device found no other damage or defect with the device.
Event or Problem Description
It was reported that there was difficulty removing the device.Vascular access was obtained via radial approach.The target lesion was located in the moderately tortuous ovarian vein.A 155 direxion hi-flo fathom-16 system was selected for use.During the procedure, an angio dynamics soft vu 5fr diagnostic catheter was inserted into the left gonadal vein after obtaining radial access via a 5fr sheath.Subsequently, the fathom guidewire was inserted through the angio dynamics catheter down into the left gonadal vein.The direxion catheter was advanced over the fathom guidewire and was able to cannulate the vein.Pushable coils were delivered after correct positioning was confirmed and embolization was completed.However, excessive resistance was noted upon pullback of the direxion catheter.The direxion and angio dynamics catheter were then removed together and the tip of the direxion was then noted to be stretched and malformed.The procedure was competed with this device.There were no patient complications reported.

• Brand Name: DIREXION HI-FLO FATHOM-16 SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10494090
• Report Number: 2134265-2020-12314
• Device Sequence Number: 2476876
• Product Code: KRA
• UDI-Device Identifier: 08714729839729
• UDI-Public: 08714729839729
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 09/04/2020

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: 05/14/2022
• Device Model Number: 84591
• Device Catalogue Number: 84591
• Device Lot Number: 0025512968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 09/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR