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

Model Number	2213-01
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the microcatheter separated.A straight tip 105cm truselect microcatheter was selected for use in an interventional radiology case.During the procedure, the microcatheter separated while loading over the fathom guidewire.Separation occurred at the transition from the flexible portion of the microcatheter to the more solid body of the microcatheter.The device was removed, and another truselect of the same size was used to successfully complete the procedure.No patient complications were reported.
Event or Problem Description
It was reported that the microcatheter separated.A straight tip 105cm truselect microcatheter was selected for use in an interventional radiology case.During the procedure, the microcatheter separated while loading over the fathom guidewire.Separation occurred at the transition from the flexible portion of the microcatheter to the more solid body of the microcatheter.The device was removed, and another truselect of the same size was used to successfully complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: returned product consisted of a truselect microcatheter.The device shaft was microscopically analyzed for any damage.The device showed a separation located 78.5cm from the hub.There were kinks located 11cm to 14cm from the tip.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.A separation and kinks were confirmed.

• Brand Name: TRUSELECT
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18778587
• Report Number: 2124215-2024-10856
• Device Sequence Number: 8382567
• Product Code: KRA
• UDI-Device Identifier: 08714729976608
• UDI-Public: 08714729976608
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K201792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/23/2025
• Device Model Number: 2213-01
• Device Catalogue Number: 2213-01
• Device Lot Number: 0032705021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown