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

Model Number 112266-003

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr.: the device was not returned for analysis.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-04443.It was reported that there was a loss of rotation on the device.A.035 non bsc wire was initially used in the left common artery and over the bifurcation in the right superficial femoral artery (sfa) and popliteal.The sfa was severely calcified so a victory 18 wire was used to access through the occlusion.The victory wire was exchanged for a v18 wire and the lesion was then predilated with a sterling sl 4x150 x150mm balloon catheter.A 2.4mm jetstream® atherectomy catheter was prepared over a thruway guidewire.The jetstream® was unable to remove much calcium and drilling slowed down then stopped.The device was put in rex mode and removed from the patient.The physician then elected to implant a 6x150x130mm eluvia¿ drug-eluting stent via a contralateral approach over the v18 guidewire.The deployment was performed very slowly, however many 'clicks' were required of the thumbwheel before the stent started to deploy.The pull grip was then pulled to deploy the remainder of the stent but a ¿snap¿ was felt as the pull grip was being retracted.At this point the pull grip and thumbwheel were no longer effective in deploying the stent.The surgeon then pulled the stent delivery system backwards to remove the system, however, this was difficult as the stent was partially deployed.As a result this caused an acute elongation of the stent and a possible fracture.The physician believed the stent had fractured into two pieces and the distal part of the stent remained in the sfa/popliteal artery and the upper proximal part in common femoral.Imaging was reviewed by the surgeon and elongation was clearly visible in the mid-section of the stent.The stent delivery system was removed and the procedure was completed with 3 non bsc stents implanted within and to the side of the fractured eluvia stent.Post dilation was performed and no further patient complications were reported.The patient status post procedure was stable.

• Brand Name: JETSTREAM® XC ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6568090
• MDR Text Key: 75215525
• Report Number: 2134265-2017-04396
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K130637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/18/2017

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 Model Number: 112266-003
• Device Catalogue Number: PV41340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2017
• Initial Date FDA Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: GUIDEWIRE: V18 WIRE