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

Model Number 112264-001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Embolism (1829)

Event Date 03/20/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a jetstream xc-2.1 atherectomy catheter in one piece, with the abbott nav6 filter guidewire separated at the tip.The device was visually examined for any shaft damage and functionality of the device.Visual examination showed no damage or issues.The device functioned as designed.The guidewire that was returned did show the tip was separated but recovered from the patient.The jetstream device showed no failures during functional analysis.The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.The dfu states the compatible guidewires that are to be used with the jetstream device.The customers state¿s an abbott nav6 filter wire was used which is not on the compatible guidewire list.Compatible guidewires: jetwire¿ 0.014 in (0.36 mm) 300 cm, thruway¿ 0.014 in (0.36 mm) 300 cm, abbott vascular hi-torque spartacore¿ 14, abbott vascular hi-torque iron man¿ 0.014 in.(b)(4).

Event Description

It was reported that there was an embolization.A 2.1 mm jetstream® xc atherectomy catheter was selected for an atherectomy procedure in the superficial femoral artery.During the procedure, the jetstream device was being used with a non-bsc filter wire and it was noted that the tip of the wire broke off in tibial peroneal trunk.The detached piece of the wire was retrieved.Subsequently, it was noted that the artery clotted off.There were no further patient complications reported.

• 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: 7428237
• MDR Text Key: 105371377
• Report Number: 2134265-2018-03056
• 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: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2019
• Device Model Number: 112264-001
• Device Catalogue Number: PV31300
• Device Lot Number: 21544503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2017
• 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
• Treatment: FILTER WIRE: ABBOTT NAV 6
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR