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

Model Number 112264-001

Device Problems Fracture (1260); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The catheter shaft and the remainder of the device were inspected for damage.Visual examination of the shaft showed 1 buckled/damaged/kink area on the shaft.The shafts outer sheath was broken under the infusion sheath.There was no leakage from the device.The damage was located approximately 88cm from the tip.The device was not completely separated the drive coil and the infusion sheath were intact.The setup of the device was performed and the device functioned as designed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is user/use error.The jetstream device dfu lists the compatible guidewire that are to be used with the jetstream device.The guidewire that was used during this procedure was not on the compatible list.Use of any non-compatible guidewire may compromise performance or damage the jetstream system.(b)(4).

Event Description

It was reported the device bogged down and the catheter material separated.A rotational atherectomy treatment procedure was being performed on a heavily calcified, long segment occlusion, located in the left superficial femoral artery (sfa).Access was obtained through the right leg, up one side and into the opposite leg.A non bsc embolic protection wire was advanced into the popliteal.A 2.1mm jetstream xc catheter as advanced to the treatment site.There was a lot of torquing the device to get it back and forth in the lesion due to the tight bifurcation.The device was being used with the blades down in one slow pass.As the treatment site was heavily calcified, the jetstream was "bogging down".It was observed that the area where the jetstream was being manipulated began to fray.The catheter material came apart from the device not far from the ¿box.¿ the procedure was completed with this device along with the use of a drug coated balloon (dcb) and placement of a 6x60 innova stent from the ostium down with great results.It was reported there was no harm to the patient.

• 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: 6824834
• MDR Text Key: 83868522
• Report Number: 2134265-2017-08466
• 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: 08/04/2017

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: 05/30/2019
• Device Model Number: 112264-001
• Device Catalogue Number: PV31300
• Device Lot Number: 20831170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2017
• Initial Date FDA Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2017
• 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
• Patient Age: 73 YR