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

Model Number 45007

Device Problems Mechanical Problem (1384); Noise, Audible (3273); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2019

Event Type  malfunction  

Event Description

It was reported that a loss a blade rotation occurred.A 2.4mm jetstream xc catheter was selected for an atherectomy procedure in a long calcified superficial femoral artery in the left leg.Atherectomy was performed through three quarters of the lesion using blades up and down; however the device seemed to be struggling and an abnormal noise was heard.Loss of blade rotation occurred while the blades were up.The device was switched back to blades down and atherectomy was repeated through the segment, device then had similar difficulties until it would not advance and lost blade rotation.Some resistance occurred when removing the device separately over the wire from the patient.The device was flushed and the wire was replaced.An attempt was made to load the device over a new wire; however it was unable to advance over new wire.The procedure was completed with a another of the same device.No patient complications were reported and the patient's status was fine.

Manufacturer Narrative

Describe event or problem: additional information.

Event Description

It was reported that a loss a blade rotation occurred.A 2.4mm jetstream xc catheter was selected for an atherectomy procedure in a long calcified superficial femoral artery in the left leg.Atherectomy was performed through three quarters of the lesion using blades up and down; however the device seemed to be struggling and an abnormal noise was heard.Loss of blade rotation occurred while the blades were up.The device was switched back to blades down and atherectomy was repeated through the segment, device then had similar difficulties until it would not advance and lost blade rotation.Some resistance occurred when removing the device separately over the wire from the patient.The device was flushed and the wire was replaced.An attempt was made to load the device over a new wire; however it was unable to advance over new wire.The procedure was completed with a another of the same device.No patient complications were reported and the patient's status was fine.It was further reported that there were no visible kinks in the thruway guidewire.The user believed there was a possibility that plaque was jammed, blocking the wire lumen or a kink in the wire lumen.There were no other devices being used at the time of this event.Angioplasty was performed.

• 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: 8288901
• MDR Text Key: 134493447
• Report Number: 2134265-2019-00548
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: 08714729889922
• Combination Product (y/n): N
• PMA/PMN Number: K130637
• 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: 02/28/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2020
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0022779599
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 01/30/2019
• Supplement Dates Manufacturer Received: 02/07/2019
• Supplement Dates FDA Received: 02/28/2019
• Patient Sequence Number: 1
• Patient Age: 74 YR