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

Model Number	2213-01
Medical Device Problem Codes	Material Perforation (2205); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the guidewire punctured through the catheter and the procedure was cancelled.A 175cm truselect catheter was selected for a prostate artery embolization procedure.During the procedure it was noted that the catheter was kinked and the wire was going through the sidewall of the catheter at the kink.The physician attempted to pull the catheter back and then removed the catheter and noted the kink.They did not have another catheter to complete the procedure, so the case was cancelled and rescheduled.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by mfr: the device was received and analysis was completed.The returned product consisted of a trueselect 175cm microcatheter.The device was visually and microscopically inspected for any damage or irregularities.The device showed damage in the form of 2 kinks located 175.5cm and 178cm from the hub.A.014 test guidewire was inserted into the lumen of the device and the wire transcended through the device with no hesitations or restrictions.Fluid was injected through the hub end of the device and the fluid dispersed from the tip.There were no indications of any holes in the devices shaft.Device analysis determined the condition of the returned device was partially consistent with the reported information.
Event or Problem Description
It was reported the guidewire punctured through the catheter and the procedure was cancelled.A 175cm truselect catheter was selected for a prostate artery embolization procedure.During the procedure it was noted that the catheter was kinked and the wire was going through the sidewall of the catheter at the kink.The physician attempted to pull the catheter back and then removed the catheter and noted the kink.They did not have another catheter to complete the procedure, so the case was cancelled and rescheduled.No patient complications were reported.

• Brand Name: TRUSELECT
• Common Device Name: 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: 12902605
• Report Number: 2134265-2021-14734
• Device Sequence Number: 14732646
• Product Code: KRA
• UDI-Device Identifier: 08714729976639
• UDI-Public: 08714729976639
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/23/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/09/2022
• Device Model Number: 2213-01
• Device Catalogue Number: 2213-01
• Device Lot Number: 0027635441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Race: Black Or African American