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

Model Number 112264-001

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: returned product consisted of a jetstream xc-2.1 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 in 1 place proximal the tip.The buckled area was approximately 84cm from the tip and functional testing is not possible due to the damage on this device.The buckling causes the fluid to back up inside of the infusion sheath and cause the infusion sheath to burst proximal of the buckling.This was the case on this device.The damaged area of the infusion sheath was approximately 88cm from the tip.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 most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Reportable based on the product analysis completed on september 21, 2017.It was reported difficulty advancing and the infusion line was deformed.A 2.1mm jetstream xc atherectomy catheter was selected for use along with a along with non bsc sheath.The target lesion was located in the chronic total occlusion (cto) mid to distal superficial femoral artery (sfa).The jetstream device was advanced through the sheath into the lesion, but was unable to advance any further.Visibility was lost and the outside of the outer coating/sheath was noted to be bunched up.The device was removed from the patient and the procedure was completed with balloon angioplasty.No patient complications were reported and the patient status was fine post procedure.However, the returned product analysis revealed a burst infusion sheath.

• 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: 6941870
• MDR Text Key: 90234964
• Report Number: 2134265-2017-09915
• 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: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2019
• Device Model Number: 112264-001
• Device Catalogue Number: PV31300
• Device Lot Number: 0020557156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1