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

Model Number 45007

Device Problem Mechanical Problem (1384)

Patient Problems Extravasation (1842); Fistula (1862); Pain (1994); Perforation of Vessels (2135)

Event Date 09/23/2020

Event Type  Injury  

Event Description

It was reported that there was a loss of rotation and perforation occurred.A 2.4mm jetstream xc catheter was used for an atherectomy procedure in the superficial femoral artery (sfa).The lesion was short, 80% stenosed, and moderately calcified.A 315cm non boston scientific wire was placed through a diagnostic catheter followed by placement of a non boston scientific embolic protection.The jetstream device was advanced.Two passes were made in blades down mode for 30 seconds.On the first pass in blades up mode, the device became stalled.The device was removed successfully over the wire from the patient.Vessel perforation was observed with extravasation.The patient experienced pain and a fistula occurred.A non boston scientific covered stent was immediately placed to resolve the artery perforation.The procedure was completed and the patient was stable.Additional heparin infusion and hospitalization was required.

Event Description

It was reported that there was a loss of rotation and perforation occurred.A 2.4mm jetstream xc catheter was used for an atherectomy procedure in the superficial femoral artery (sfa).The lesion was short, 80% stenosed, and moderately calcified.A 315cm non boston scientific wire was placed through a diagnostic catheter followed by placement of a non boston scientific embolic protection.The jetstream device was advanced.Two passes were made in blades down mode for 30 seconds.On the first pass in blades up mode, the device became stalled.The device was removed successfully over the wire from the patient.Vessel perforation was observed with extravasation.The patient experienced pain and a fistula occurred.A non boston scientific covered stent was immediately placed to resolve the artery perforation.The procedure was completed and the patient was stable.Additional heparin infusion and hospitalization was required.It was further reported that the catheter used during this procedure was an imager straight 65cm.038 catheter.

Manufacturer Narrative

A2: age at time of event: patient was over 65 years old.

• 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: 10609737
• MDR Text Key: 209270464
• Report Number: 2134265-2020-13547
• Device Sequence Number: 1
• Product Code: MCW
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2020
• Patient Sequence Number: 1
• Treatment: ABBOTT BARE WIRE 315 CM; ABBOTT BARE WIRE 315 CM; ABBOTT NAV6 EMBOSHIELD; ABBOTT NAV6 EMBOSHIELD; IMAGER STRAIGHT 65CM .038"; ABBOTT BARE WIRE 315 CM; ABBOTT NAV6 EMBOSHIELD
• Patient Outcome(s): Hospitalization; Required Intervention