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

Model Number 45007

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2020

Event Type  malfunction  

Event Description

It was reported that a loss of rotation occurred during use.The target lesion was located in the superficial femoral artery.A 2.1mm jetstream xc catheter was selected for use.During the procedure after a period of atherectomy, the motor sounded weak and quiet then stopped.The device was completely rebooted and a second attempt was made; however the same issue occurred.The procedure was successfully completed with another jetstream device.There were no patient complications reported.

Manufacturer Narrative

Correction: initial bsc aware date was reported as (b)(6) 2020.Additional information confirmed bsc aware date is (b)(6) 2020.Device evaluated by mfr: the shaft and the remainder of the device was inspected for damage.Visual examination showed a severe kink on the catheter shaft located 62cm from the tip.The functionality of the device was checked by setting up the product per the instructions for use.The device primed as designed.The device was activated, and the blades did spin as designed when the device was straight, and no bends were in the shaft.When the device was bent at the kinked area this causes drive coil constriction and the device would stall.

Event Description

It was reported that a loss of rotation occurred during use.The target lesion was located in the superficial femoral artery.A 2.1mm jetstream xc catheter was selected for use.During the procedure after a period of atherectomy, the motor sounded weak and quiet then stopped.The device was completely rebooted and a second attempt was made; however the same issue occurred.The procedure was successfully completed with another jetstream device.There were no patient complications reported.

• 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: 10678178
• MDR Text Key: 211362345
• Report Number: 2134265-2020-14126
• 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: 11/03/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2021
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0024706886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 10/14/2020
• Supplement Dates FDA Received: 11/03/2020
• Patient Sequence Number: 1