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

Model Number 84591

Device Problems Break (1069); Defective Device (2588); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2022

Event Type  malfunction  

Event Description

It was reported that the catheter was fractured.A direxion hi-flo fathom-16 system was selected for use.During the procedure, advancement of coils was difficult due to microcatheter stretching towards microcatheter tip.It was noted that the catheter fractured during attempted advancement and withdrawal, within the base catheter, with just mild to moderate force.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.The device shaft was microscopically analyzed for any damage.The guidewire was stuck in the device.The device showed a fractured shaft located 40.2cm from the hub.The device was not completely separated, the inner liner was still intact.The inner liner was stretched and constricting the guidewire from movement.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.No other issues were identified during the product analysis.

Event Description

It was reported that the catheter was fractured.A direxion hi-flo fathom-16 system was selected for use.During the procedure, advancement of coils was difficult due to microcatheter stretching towards microcatheter tip.It was noted that the catheter fractured during attempted advancement and withdrawal within base catheter with just mild to moderate force.The procedure was completed with a different device.No patient complications were reported.

• Brand Name: DIREXION HI-FLO FATHOM-16 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; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16259087
• MDR Text Key: 308586288
• Report Number: 2124215-2023-01423
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729839712
• UDI-Public: 08714729839712
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2024
• Device Model Number: 84591
• Device Catalogue Number: 84591
• Device Lot Number: 0028721418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2022
• 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
• Patient Sex: Male