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

Model Number	84592
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976); Material Integrity Problem (2978); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire coating peeled.A direxion fathom-16 system catheter infusion was selected for use in a hepatocarcinoma embolization.During the preparation, the direxion microcatheter with a preloaded guidewire was passed inside the coil.The guidewire was removed from the microcatheter and placed it in saline.The coil containing the microcatheter was flushed.The microcatheter was removed.Resistance was noted upon insertion due to the bending of the microguide and was unable to enter the direxion.It was observed that the guidewire was not smooth and roughness in the guidewire's tip, as if the hyrophilic coating was peeled off after proper hydration.Lastly, the direxion was placed back on the coil.The coil was advanced.However, the shaft was bent and fractured exposing the pebax layer.The procedure was completed with another of the same device.No patient complications reported.
Event or Problem Description
It was reported that the guidewire coating peeled.A direxion fathom-16 system catheter infusion was selected for use in a hepatocarcinoma embolization.During the preparation, the direxion microcatheter with a preloaded guidewire was passed inside the coil.The guidewire was removed from the microcatheter and placed it in saline.The coil containing the microcatheter was flushed.The microcatheter was removed.Resistance was noted upon insertion due to the bending of the microguide and was unable to enter the direxion.It was observed that the guidewire was not smooth and roughness in the guidewire's tip, as if the hyrophilic coating was peeled off after proper hydration.Lastly, the direxion was placed back on the coil.The coil was advanced.However, the shaft was bent and fractured exposing the pebax layer.The procedure was completed with another of the same device.No patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a direxion microcatheter and a guide wire in the shaft of the catheter.There was blood and contrast in the device.The proximal end of the guide wire was found to be protruding out from the distal tip of the device.The guide wire was separated from the microcatheter during lab analysis.Analysis of the guide wire, tip, inner/outer shaft included microscopic and visual inspection.Inspection revealed the outer shaft was fractured 9.4cm from the strain relief with the inner shaft stretched between the fracture faces.The coating of the inspection of the rest of the device found no other damage or defect.As the guide wire was removed from the microcatheter, dried blood and contrast came out form the microcatheter shaft.After flushing the direxion shaft, the distal tip of the guide wire was inserted into the hub of the microcatheter, and the wire could only advance for 9.4cm and then stopped.The id (inner diameter) of the distal and proximal ends of the direxion were measured with calibrated plug gage.Both ends measured.021, meeting the specification.

• Brand Name: DIREXION 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: 10626615
• Report Number: 2134265-2020-13701
• Device Sequence Number: 14342446
• Product Code: KRA
• UDI-Device Identifier: 08714729839644
• UDI-Public: 08714729839644
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 10/29/2020

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: 01/29/2022
• Device Model Number: 84592
• Device Catalogue Number: 84592
• Device Lot Number: 0025128732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1