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

Model Number 84591

Device Problems Entrapment of Device (1212); Stretched (1601)

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

Event Date 08/17/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: the direxion microcatheter was returned for analysis.The device was stuck in the angiographic catheter that was used for the procedure.It was noticed that the shaft was fractured located 46.5cm and 55cm from the hub.The returned angio catheter was a 5fr.035 internal diameter.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The device was confirmed for being stuck in the returned angiographic catheter, as well as shaft fractures.

Event Description

Reportable based on device analysis completed on 08-sep-2022.It was reported that the catheter got stuck and stretched.A 130cm direxion hi-flo catheter-infusion was selected for use.However, the device appeared to get stuck inside the base of the catheter and stretched.It took some time to get the catheter positioned into the original location.No patient complications were reported.However, returned device analysis revealed shaft was fractured.

• 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: 15513547
• MDR Text Key: 301498508
• Report Number: 2124215-2022-37882
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2022

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 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
• Date Returned to Manufacturer: 08/23/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 09/30/2022
• 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