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

Model Number 2213-02

Device Problem Material Perforation (2205)

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

Event Date 11/07/2022

Event Type  malfunction  

Event Description

It was reported that there was a hole in the microcatheter located approximately 10 cm from the device tip.A selective mc single bern 130 cm was selected for use to deliver the non-bsc liquid embolic system during the embolization procedure.When the liquid embolic system was administered, it was noted that there was a hole in the microcatheter, approximately 10 cm from the device tip.The microcatheter was removed and exchanged for another microcatheter.The procedure was successfully completed and there were no reported adverse consequences to the patient.

Manufacturer Narrative

Device media analysis: the product was returned to boston scientific for analysis.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 revealed a hole in the microcatheter shaft located approximately 119cm from the hub.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 revealed no additional damage or irregularities.Device analysis determined the condition of the returned device was consistent with the reported information.

Event Description

It was reported that there was a hole in the microcatheter located approximately 10 cm from the device tip.A selective mc single bern 130 cm was selected for use to deliver the non-bsc liquid embolic system during the embolization procedure.When the liquid embolic system was administered, it was noted that there was a hole in the microcatheter, approximately 10 cm from the device tip.The microcatheter was removed and exchanged for another microcatheter.The procedure was successfully completed and there were no reported adverse consequences to the patient.

• Brand Name: TRUSELECT
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15886871
• MDR Text Key: 307604752
• Report Number: 2124215-2022-48638
• Device Sequence Number: 1
• Product Code: KRA
• 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,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2213-02
• Device Catalogue Number: 2213-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1