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

Model Number	2213-01
Medical Device Problem Codes	Difficult to Flush (1251); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by mfr: the returned product consisted of a trueselect 130cm microcatheter.The device was visually and microscopically inspected for any damage or irregularities.The device showed multiple bends and kinks along the shaft.The microscopic inspection did show a hole in the microcatheter shaft located approximately 120cm from the hub.The internal area of the hole did show metal braid damage.A.014 test guidewire was inserted into the device and the wire transcended through the device with a slight restriction due to the shaft damage.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.Device analysis determined the condition of the returned device was consistent with the reported information.The device was confirmed for bends, kinks, and a hole in the shaft.
Event or Problem Description
It was reported that the catheter shaft ruptured.A truselect infusion catheter was selected for use to treat hepatocellular carcinoma (hcc) using y90.Prior to infusing y90, a contrast run was performed.The physician observed that the contrast appeared more proximal than expected.The physician then opted to embolize a distal vessel with gelfoam prior to delivering the y90 dose.However, the gelfoam could not be flushed through the catheter.The catheter was removed from the patient and flushed with saline.A small hole at the distal end of the catheter was observed.Saline was shooting out of it.A new device, same model, was used to complete the procedure.There were no patient complications.

• 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: 17439773
• Report Number: 2124215-2023-40125
• Device Sequence Number: 14102708
• Product Code: KRA
• UDI-Device Identifier: 08714729976615
• UDI-Public: 08714729976615
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 08/01/2023

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: 05/18/2025
• Device Model Number: 2213-01
• Device Catalogue Number: 2213-01
• Device Lot Number: 0031657027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown