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 07/01/2022

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 19aug2022.It was reported that the device got stuck inside the base catheter and was stretched.A direxion hi-flo fathom-16 system was selected for use.During the procedure, it was noted that the device got stuck inside the base catheter and eventually got stretched.It took time for the device to return to its initial position.No patient complications were reported.However, device analysis revealed 2 shaft fractures located 53.5cm and 68cm from the hub.

Manufacturer Narrative

Date of event is an estimated date based on the aware date as the exact event date was not reported.Device evaluated by manufacturer: the device was returned for analysis.The device returned stuck inside a 5fr cook angiographic catheter.The devices shaft showed stretching and 2 fractures located 53.5cm and 68cm from the hub.It was attempted to separate the direxion from the angiographic catheter; however, the two devices could not be separated.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
• 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: 15412091
• MDR Text Key: 303338323
• Report Number: 2124215-2022-33892
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2022

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: 08/08/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 09/13/2022
• 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