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

Model Number	2213-01
Medical Device Problem Codes	Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	09/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 - date of event: the event date was approximated to 09/27/2024 based on the date that boston scientific became aware of the event.
Event or Problem Description
It was reported that the patient was admitted to the hospital beyond the standard of care.A tru-select was selected for use in the therasphere procedure.When the plunger on the therasphere administration set was pressed to deliver the therasphere microspheres, there was resistance encountered, causing the truselect to burst.As a result, the therasphere dose was mis-administered to the gastroduodenal artery (gda).When the truselect was removed, the physician observed a hole in the microcatheter that was thought to be caused from a kink.The patient was admitted to the hospital beyond the standard of care.No further details were provided despite request by boston scientific.
Event or Problem Description
It was reported that the patient was admitted to the hospital beyond the standard of care.A truselect was selected for use in the therasphere procedure.When the plunger on the therasphere administration set was pressed to deliver the therasphere microspheres, there was resistance encountered, causing the truselect to burst.As a result, the therasphere dose was mis-administered to the gastroduodenal artery (gda).When the truselect was removed, the physician observed a hole in the microcatheter that was thought to be caused from a kink.The patient was admitted to the hospital beyond the standard of care.No further details were provided despite request by boston scientific.It was further reported via attached voluntary medwatch/maude report that more than 50% of the target dose was mis-administered to the gastroduodenal artery (gda).

• 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: 20526464
• Report Number: 2124215-2024-66103
• Device Sequence Number: 18409655
• Product Code: KRA
• UDI-Device Identifier: 08714729976615
• UDI-Public: 08714729976615
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/17/2026
• Device Model Number: 2213-01
• Device Catalogue Number: 2213-01
• Device Lot Number: 0034451117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 01/10/2025
• Date Device Manufactured: 07/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian