MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUSELECT; CATHETER, CONTINUOUS FLUSH

Model Number 2213-01

Device Problems Difficult to Remove (1528); Stretched (1601)

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

Event Date 08/01/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: approximated to (b)(6) 2021 based on the date boston scientific was made aware of the event.(b)(6).

Event Description

It was reported that the device was difficult to remove.A truselect 175cm straight microcatheter was selected for use in a prostate artery embolization procedure.Upon removal from the patient, it was reported that there was difficulty removing the device, causing the device to stretch near the hub and become unusable.A new microcatheter was used to complete the procedure.No patient complications were reported.

• Brand Name: TRUSELECT
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12434653
• MDR Text Key: 270295427
• Report Number: 2134265-2021-11254
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729976639
• UDI-Public: 08714729976639
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/07/2021

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: 05/27/2022
• Device Model Number: 2213-01
• Device Catalogue Number: 2213-01
• Device Lot Number: 0027397345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 09/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1