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

Model Number	29462
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a guidewire tip fracture occurred.The target area was located in the lateral femoral artery (lfa).A 180cm renegade hi-flo 135cm 20 preload fathom system was selected for use.During the procedure, after the coil was deployed and pushed forward using a guidewire, it was noted that the wire hooked with the coil.Furthermore, when the device was withdrawn out of the patient's body within the catheter, it was found out that the tip of the guidewire was fractured.The device was completely removed within the catheter without needing additional intervention.The procedure was completed with another of the same device.No patient complications were reported and patient's status was stable.
Event or Problem Description
It was reported that a guidewire tip fracture occurred.The target area was located in the lateral femoral artery (lfa).A 180cm renegade hi-flo 135cm 20 preload fathom system was selected for use.During the procedure, after the coil was deployed and pushed forward using a guidewire, it was noted that the wire hooked with the coil.Furthermore, when the device was withdrawn out of the patient's body within the catheter, it was found out that the tip of the guidewire was fractured.The device was completely removed within the catheter without needing additional intervention.The procedure was completed with another of the same device.No patient complications were reported and patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The renegade was visually and microscopically examined and identified no damage on the device.The returned fathom guidewire was also analyzed and no damaged was noticed.The tip of the guidewire was intact and no fractures or separations were noticed.Inspection of the remainder of the device revealed no other damage or irregularities.

• Brand Name: RENEGADE HI-FLO FATHOM SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8316256
• Report Number: 2134265-2019-00687
• Device Sequence Number: 13778995
• Product Code: KRA
• UDI-Device Identifier: 08714729790860
• UDI-Public: 08714729790860
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2019

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: 01/09/2021
• Device Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 21595105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 02/07/2019
• Supplement Report FDA Received Date: 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR