MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM XC; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 45007

Device Problems Display or Visual Feedback Problem (1184); Leak/Splash (1354); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2018

Event Type  malfunction  

Event Description

It was reported that the device was leaking.A 2.1mm jetstream xc catheter was selected for use for an atherectomy procedure in the superficial femoral artery.The jetstream xc catheter had made three passes in the stenosed area of the artery and successfully completed atherectomy.The physician was removing the catheter out of the patient using rex mode, when it was observed that blood was leaking out of the plastic tubing near the console.This leak was not observed at the beginning of the procedure.An error message indicating "bubble detected" also appeared.The physician then manually backed the jetstream xc catheter off of the guidewire and the procedure was successfully completed with no patient complications reported.

Event Description

It was reported that the device was leaking.A 2.1mm jetstream xc catheter was selected for use for an atherectomy procedure in the superficial femoral artery.The jetstream xc catheter had made three passes in the stenosed area of the artery and successfully completed atherectomy.The physician was removing the catheter out of the patient using rex mode, when it was observed that blood was leaking out of the plastic tubing near the console.This leak was not observed at the beginning of the procedure.An error message indicating "bubble detected" also appeared.The physician then manually backed the jetstream xc catheter off of the guidewire and the procedure was successfully completed with no patient complications reported.Device evaluated by mfr: visual examination showed no damage on the catheter shaft or roller pump tubing for the infusion line.Visual examination of the aspiration tubing showed a cut/hole in the tubing.With this damage leakage would be present.The damage is consistent with the incorrect insertion of the aspiration tubing into the roller pump at the start of the procedure.With the tubing not inserted fully and the door shut this would cause a pinch point against the tubing and cause the cut/hole that was noticed.The device could not be set-up and functionally tested due to the leak may cause console damage in the form of fluid flowing into the mechanical components.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• Brand Name: JETSTREAM XC
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7931518
• MDR Text Key: 122632255
• Report Number: 2134265-2018-61547
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: 08714729889892
• Combination Product (y/n): N
• PMA/PMN Number: K133023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2020
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0022140890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR