MAUDE Adverse Event Report: BOSTON SCIENTIFIC JETSTREAM XC 2.4 ATHERECTOMY CATHETER

Model Number 112266-001

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2014

Event Type  Other  

Event Description

A boston scientific sales representative reported the following: a jetstream xc 2.4 atherectomy set was being used to treat an occluded viabahn graft.The physician noted that the catheter was not bringing saline back to the holding bag.The physician attempted to retract the catheter but was unable to do so as the catheter became stuck on the guide wire and would not move.The physician decided to remove the catheter and guide wire as a unit and terminated the atherectomy procedure.The physician then chose to complete the procedure using angioplasty and drug eluding balloons.The overall procedure was successful in restoring blood flow.

Manufacturer Narrative

Quality assurance product analysis received and examined the returned jetstream xc-2.4 catheter and observed that the wire stuck inside the catheter was a filterwire guide wire.The rest of the unit appeared to be in good condition with no other observable defects or damage.The device would not activate with the filterwire stuck inside and therefore a functional test could not be performed.The weld at the tip of the catheter was separated to investigate the guide wire lumen.The bushing and proximal cap were plugged with teflon.The cause of the problem is the guide wire losing coating and occluding the bushing at the distal end of the catheter.The filterwire guide wire is not listed in the jetstream system ifu as a compatible device.In this reported event, the jetstream catheter was being used in a previously placed stent when it allegedly stalled.The treatment of in-stent restenosis is an off-label use of the jetstream atherectomy system.This event is considered to be a reportable event due to the association between the jetstream device and noted event.

• Brand Name: JETSTREAM XC 2.4 ATHERECTOMY CATHETER
• Type of Device: ATHERECTOMY CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC; minneapolis MN
• Manufacturer Contact: linda mcdonald ; 9055 evergreen blvd., n.w.; minneapolis, MN 55433 ; 7249407412
• MDR Report Key: 4433257
• MDR Text Key: 18291057
• Report Number: 2183460-2015-00002
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2014

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: 03/03/2016
• Device Model Number: 112266-001
• Device Catalogue Number: JETSTREAM
• Device Lot Number: 166638
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/22/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2014
• Initial Date FDA Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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 Outcome(s): Required Intervention