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

Model Number 84592

Device Problems Fracture (1260); Failure to Advance (2524)

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

Event Date 04/27/2022

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 17may2022.It was reported that the device was fractured at the hub.The stenosed target lesion was located in the moderately tortuous and moderately calcified left prostate artery.A ngmc/fathom/021/bern/1ro/130 direxion fathom-16 system was selected for use.During the procedure, it was noted that the device was fractured at the proximal hub.The device was removed intact and the procedure was completed with another of the same device.There were no complications reported.However, device investigations revealed that the device was fractured 25.3cm from the hub.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The device shaft was analyzed for any damage.The devices shaft showed a fracture located 25.3cm from the hub.The fracture looked to be consistent with a tensile force breaking.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.A fracture was confirmed.

• Brand Name: DIREXION 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14632717
• MDR Text Key: 293570958
• Report Number: 2134265-2022-06080
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729839637
• UDI-Public: 08714729839637
• 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
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2024
• Device Model Number: 84592
• Device Catalogue Number: 84592
• Device Lot Number: 0028789815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Race: White