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

Model Number 29462

Device Problems Difficult to Insert (1316); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a renegade hi-flo micro-catheter stuck inside a terumo guide catheter.The device was analyzed as received.The device was stuck inside of a 4fr terumo guide catheter.The renegade device showed a fracture located 36.4cm from the hub.There was extreme tensile force applied to the device due to the stretching that was noticed.There were multiple kinks throughout the returned devices.The devices were soaked in an 37 degree celsius bath for a period of 72hrs to try and loosen the devices up to pull the renegade from the guide catheter; however, the devices could not be separated.A.014 fathom guidewire was attempted to be inserted into the hub end of the device; however, the guidewire would not enter due to contrast being hardened in the hub.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

Event Description

Reportable based on device analysis completed on (b)(6) 2019.It was reported that friction occurred.A 140cm/115cm renegade hi-flo fathom system was selected for use.During procedure, a non bsc catheter was used to perform celiac trunk angiography for mapping hepatic vascular anatomy.Subsequently, hi-flo microcatheter system was introduced through celiac trunk to proper hepatic artery; however, friction was very large.To find where the problem was, the wire was retracted and the hiflo catheter was re-introduced but the wire could not be introduced again into the catheter.Consequently, it was speculated that there was something wrong with the hub.The procedure was completed with different device.No patient complications were reported and the patient is stable.However, device analysis revealed device fracture.It was further reported that the fracture may have been caused by pulling or pushing the microcatheter with force.

• Brand Name: RENEGADE HI-FLO FATHOM SYSTEM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road,; cork ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8491952
• MDR Text Key: 141214534
• Report Number: 2134265-2019-03562
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K140329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2019

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
• Device Operator: Health Professional
• Device Model Number: 29462
• Device Catalogue Number: 29462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 04/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1