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

Model Number 2213-01

Device Problems Fracture (1260); Difficult to Remove (1528); Failure to Advance (2524)

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

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the returned product consisted of a truselect 175cm microcatheter.The device shaft was microscopically analyzed for any damage.The device showed multiple bends and kinks along the entire shaft.The distal end of the shaft showed multiple fractures.The distal end looked to have a degrading issue.The distal shaft looked to be cracked and dried out.Fourier-transform infrared spectroscopy (ftir) was completed on this device, and it was noticed that an anti-bacterial wipe was used to wipe down the distal shaft.Anti-terra u is a wetting and dispersing additive that are in some over the counter bacterial wipes.The solution caused the outside shaft to deteriorate and degrade.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

Event Description

It was reported that fractures occurred.A 175cm truselect and a 014x200cm fathom guidewire were selected for use in a y90 procedure to treat hepatocellular carcinoma (hcc).The catheter was advanced with the guidewire through the tortuous anatomy.The guidewire was removed to take an angiogram.The guidewire was advanced again in attempt to advance the catheter a little further in the vessel where treatment was planned; however, advancement difficulty occurred due to the "curly q" in the vessel.After multiple unsuccessful attempts, the fathom and truselect were removed with resistance.Multiple fractures were noted on the truselect.A new truselect and fathom were used to complete the procedure.There were no patient complications.

• Brand Name: TRUSELECT
• Type of Device: 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: 18852310
• MDR Text Key: 337312589
• Report Number: 2124215-2024-13719
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2213-01
• Device Catalogue Number: 2213-01
• Device Lot Number: 0029413521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1