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

Model Number 112266-001

Device Problems Aspiration Issue (2883); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

It was reported that a loss of aspiration occurred.A 2.4mm jetstream xc atherectomy catheter was selected for a right superficial femoral artery (sfa) atherectomy procedure.During the procedure the catheter was placed in the right sfa.It ran for about 20 seconds and then lost aspiration.The device stalled and would not spin.The procedure was completed with a different device.There were no patient complications reported and the patient's status was fine.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a jetstream xc-2.4 atherectomy catheter in one piece.The device was visually examined for any shaft damage and also functionality of the device.Visual examination showed no damage to the catheter shaft.Functional testing of the device was completed by connecting it to the jetstream console.When the forward button was depressed, the device did not function as intended.The motor would not activate.The back cover was removed on the pod and it was noticed that the bearing was rusted and had traces of blood and saline on it.After the cleaning of the bearing and turning the bearing shaft manually the bearing was still not able to spin freely.Functional analysis was also done by completing the aspiration testing of the device.Test results showed that the device aspirated within specifications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that a loss of aspiration occurred.A 2.4mm jetstream® xc atherectomy catheter was selected for a right superficial femoral artery (sfa) atherectomy procedure.During the procedure the catheter was placed in the right sfa.It ran for about 20 seconds and then lost aspiration.The device stalled and would not spin.The procedure was completed with a different device.There were no patient complications reported and the patient's status was fine.

• 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: 6303495
• MDR Text Key: 66663033
• Report Number: 2134265-2017-00658
• 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,Followup
• Report Date: 01/18/2017

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: 09/30/2018
• Device Model Number: 112266-001
• Device Catalogue Number: PV41340
• Device Lot Number: 19821267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2017
• Initial Date FDA Received: 02/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2016
• 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