MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK JETSTREAM® XC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 112266-001

Event Date 03/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: returned product consisted of a jetstream xc-2.4 atherectomy catheter.The device was visually examined for any shaft damage.Visual examination showed damage on the shaft.It was noticed that the catheter shaft was buckled.The buckled area was 1.5cm from the tip.Functional testing was completed and the device functioned as designed pertaining to the rotation of the device.The buckling on the shaft causes the fluid to back up inside of the infusion sheath and causes the infusion sheath to burst proximal of the buckling.This was the case on this device.When this happens the device leaks fluid from the damaged area and the performance of the device diminishes.Buckling is usually cause by the device being pushed, pulled and torqued in the introducer sheath during the procedure.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).

Event Description

It was reported that a hole occurred in the catheter shaft.A 2.4mm jetstream® xc atherectomy catheter was selected for a lower extremity (le) atherectomy procedure in the superficial femoral artery.Upon removal from the sheath, a hole was noted on the outside of the catheter shaft.The hole was located on a portion of the device that was inside the patient.A leak occurred at the location of the hole.No error message displayed.Procedure was completed with this device.There were no patient complications.

• Brand Name: JETSTREAM® XC ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7408732
• MDR Text Key: 104842290
• Report Number: 2134265-2018-02966
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2018

1 Device 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: 10/30/2019
• Device Model Number: 112266-001
• Device Catalogue Number: PV41340
• Device Lot Number: 0021444569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2018
• Initial Date FDA Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial