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

Model Number	84591
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 29-aug-2018.It was reported that friction occurred between the device and the guide catheter.A 130/27 direxion hi-flo fathom-16 system was selected for use.During procedure, it was noted that there were friction between the preloaded direxion hi-flo system and the 0.038 non- bsc guide catheter.The procedure was completed with a different device.No patient complications were reported.However, device analysis revealed a fractured shaft.The device was returned for analysis.The returned product consisted of a direxion micro-catheter with a cordis.038 guide catheter.The shaft was microscopically examined.The device showed damage in the form of a fractured shaft in 1 location.The location of the fracture was 61.5cm from the hub.The device was not completely separated, the inner liner was still intact.The outer diameter (od) of the direxion catheter was measured on the led micrometer.The maximum od that was measured was.0383.The returned.038 cordis guide catheter (id.041) was hydrated with fluid and the direxion catheter was inserted into the guide catheter and the device transcended through with no hesitations or restrictions.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• 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: 7897481
• Report Number: 2134265-2018-61153
• Device Sequence Number: 169896
• Product Code: KRA
• UDI-Device Identifier: 08714729839682
• UDI-Public: 08714729839682
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 09/21/2018

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: 05/22/2020
• Device Model Number: 84591
• Device Catalogue Number: 84591
• Device Lot Number: 0022156810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 09/21/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER- CORDIS 0.038 TEMPO