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

Model Number 112266-001

Device Problem Entrapment of Device (1212)

Patient Problem Embolism (1829)

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that there was distal embolization and the device became entrapped on the guidewire.A 2.4 mm jetstream® xc atherectomy catheter was selected for an atherectomy procedure in the calcified common femoral artery.During the procedure, the jetstream device bound up with a non-bsc wire and became welded to it.The entire device and non-bsc filter basket were removed losing access to the vessel.Open surgery was required to remove the embolic material.There were no further patient complications reported.The patient was stable post surgery.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a jetstream xc-2.4 atherectomy catheter in one piece with a filter wire.Visual inspection of the device revealed that the guidewire was stuck in the device.The guidewire lumen and the catheter shaft were checked for damage.The shaft showed no damage.The devices tip showed that the device was run over the coils of the guidewire.The coils were also stuck inside of the bushing and the proximal cap housing.It was noticed that the guidewire used during the procedure was an abbott bare filter wire.This wire is not on the compatible guidewire list.If the customer site used a non-compatible guidewire they may experience guidewire issues.Functionality was checked by setting up the device on the jetstream console and the device functioned as designed.The shaft of the catheter showed some buckling which is consistent with interaction with the introducer sheath.Inspection of the remainder of the device, revealed no other damage or irregularities.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 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.The wire used was an abbott bare filter wire.Use of any non-compatible guidewire may compromise performance or damage the jetstream system.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 distal embolization and the device became entrapped on the guidewire.A 2.4mm jetstream xc atherectomy catheter was selected for an atherectomy procedure in the calcified common femoral artery.During the procedure, the jetstream device bound up with a non-bsc wire and became welded to it.The entire device and non-bsc filter basket were removed losing access to the vessel.Open surgery was required to remove the embolic material.There were no further patient complications reported.The patient was stable post surgery.

• 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: 7341607
• MDR Text Key: 102494085
• Report Number: 2134265-2018-01973
• 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: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2019
• Device Model Number: 112266-001
• Device Catalogue Number: PV41340
• Device Lot Number: 21591843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2018
• 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: ABBOTT NAV6; GUIDEWIRE: ABBOTT BARE WIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR