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

Model Number	M001394111550
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of a truselect 155cm bern microcatheter.The device was visually and microscopically inspected for any damage or irregularities.The truselect showed multiple small bends throughout the catheter length.There were two small kinks located at the distal end of the catheter shaft located 16.5cm from the tip.Leak testing was performed using a syringe of fluid injecting into the hub to verify any fluid exiting the catheter shaft.A leak was verified at approximately 23cm from the hub.Microscopic analysis showed a slice or cut in the catheter shaft at this location.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The evidence of the analysis shows that the damage is consistent with a cut or slice from a sharp object such as a razor blade or a scalpel during the procedure.The cut or slice was deep enough to cause internal braid damage.
Event or Problem Description
Reportable based on device analysis completed on 16oct2020.It was reported that a catheter leak occurred.The target lesion was located in segment 4 of the liver.A 155cm truselect was selected for a pre y90 mapping of colorectal metastases.During laser magnetic resonance (lmr), prior to administering the melanoma-associated antigen (maa), a couple of power injections at 700 psi were performed.After the injections, saline was pushed through the catheter.A pooling of saline was noted at approximately 3cm from the hub along the vestimid coating outside the patient.The procedure was completed with a 2.4 microcatheter.There were no patient complications.However, device analysis revealed a slice in the catheter shaft 23cm from the hub.

• Brand Name: TRUSELECT
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10791373
• Report Number: 2134265-2020-15219
• Device Sequence Number: 13735198
• Product Code: KRA
• UDI-Device Identifier: 08714729976660
• UDI-Public: 8714729976660
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K201792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2020

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: 07/28/2021
• Device Model Number: M001394111550
• Device Lot Number: 0025779324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 11/05/2020
• Patient Sequence Number: 1