MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION TRANSEND-14 SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number 84590

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Vasoconstriction (2126)

Event Date 07/05/2022

Event Type  Injury  

Event Description

It was reported that the vessel went into spasm and could not remove the device.A 155cm direction catheter infusion was selected for use.During the procedure the vessel went into spasm.Upon removal, the device could not be removed and the microcatheter got broke at the hub twice.The patient was given a glyceryl trinitrate and removed the device successfully without incident.The procedure was completed with another of same device.No further patient complications were reported, and patient was stable post procedure.

• Brand Name: DIREXION TRANSEND-14 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: 15136068
• MDR Text Key: 296946438
• Report Number: 2124215-2022-24697
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729839781
• UDI-Public: 08714729839781
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K142259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2023
• Device Model Number: 84590
• Device Catalogue Number: 84590
• Device Lot Number: 0028492906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2021
• 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 Outcome(s): Required Intervention