MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM XC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 45007

Device Problems Entrapment of Device (1212); Mechanical Problem (1384); Noise, Audible (3273)

Patient Problem Embolism (1829)

Event Date 03/12/2019

Event Type  Injury  

Event Description

It was reported that the device became entrapped on the guidewire, a loss of rotation occurred and the patient experienced an embolism.Vascular access was gained via the right common femoreal artery to treat the left leg using a non-bsc 7fr braided sheath.The aortic bifurcation had a sharp angle, requiring the braided sheath to provide support to gain access to the contralateral side.A jetstream xc atherectomy catheter and a jetstream console were selected for use in an atherectomy procedure in the heavily calcified distal popliteal artery, just past the knee joint.A non-bsc filter was in place and the jetstream catheter was advanced over a 315cm non-bsc guidewire.Two runs were performed with blades down then with blades up for another run.The catheter was moving up and down the wire initially without issue.The rex function was used every 30 seconds.At no point was the distal tip of the catheter sitting on the wire during operation or while the tip was rotating for longer than a few seconds, as confirmed by the wire loop in the wire guard increasing and decreasing during the operation.As the case progressed, the catheter became more and more difficult to move along the wire.A second proximal lesion in the superficial femoral artery (sfa) was treated with 1 to 2 passed on blades down; however the catheter became impossible to move along the wire.In addition, despite pressing the forward button on the jetstream, the motor on the jetstream console would no longer rotate.There was a small wirrr sound for about a second, but then the jetstream was silent.This occurred at about 10 minutes of jetstream usage time, as indicated on the jetstream console.As a result, the entire system had to be pulled out of the leg and through the sheath as one unit.The patient subsequently had tibial emboli that was treated successfully but resulted in longer procedure time.

Event Description

It was reported that the device became entrapped on the guidewire, a loss of rotation occurred and the patient experienced an embolism.Vascular access was gained via the right common femoral artery to treat the left leg using a non-bsc 7fr braided sheath.The aortic bifurcation had a sharp angle, requiring the braided sheath to provide support to gain access to the contralateral side.A jetstream xc atherectomy catheter and a jetstream console were selected for use in an atherectomy procedure in the heavily calcified distal popliteal artery, just past the knee joint.A non-bsc filter was in place and the jetstream catheter was advanced over a 315cm non-bsc guidewire.Two runs were performed with blades down then with blades up for another run.The catheter was moving up and down the wire initially without issue.The rex function was used every 30 seconds.At no point was the distal tip of the catheter sitting on the wire during operation or while the tip was rotating for longer than a few seconds, as confirmed by the wire loop in the wire guard increasing and decreasing during the operation.As the case progressed, the catheter became more and more difficult to move along the wire.A second proximal lesion in the superficial femoral artery (sfa) was treated with 1 to 2 passed on blades down; however the catheter became impossible to move along the wire.In addition, despite pressing the forward button on the jetstream, the motor on the jetstream console would no longer rotate.There was a small whirr sound for about a second, but then the jetstream was silent.This occurred at about 10 minutes of jetstream usage time, as indicated on the jetstream console.As a result, the entire system had to be pulled out of the leg and through the sheath as one unit.The patient subsequently had tibial emboli that was treated successfully but resulted in longer procedure time.It was further reported that no error message displayed.No visible defects were noted on the catheter.Percutaneous transluminal angioplasty was performed to resolve the emboli.The jetstream runtime was 11 minutes.A jetstream 2.3/3.4 was used to complete the procedure.The patient's status post procedure was stable.

• Brand Name: JETSTREAM XC ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8440035
• MDR Text Key: 139446042
• Report Number: 2134265-2019-02748
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K130637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2020
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0022585692
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 03/21/2019
• Supplement Dates Manufacturer Received: 04/03/2019
• Supplement Dates FDA Received: 04/24/2019
• Patient Sequence Number: 1
• Treatment: FILTER: DISTAL NAV6 EMBOSHIELD; FILTER: DISTAL NAV6 EMBOSHIELD; GUIDEWIRE: 315CM ABBOTT BAREWIRE; GUIDEWIRE: 315CM ABBOTT BAREWIRE; SHEATH: 7FR ARROW BRAIDED; SHEATH: 7FR ARROW BRAIDED; FILTER: DISTAL NAV6 EMBOSHIELD; GUIDEWIRE: 315CM ABBOTT BAREWIRE; SHEATH: 7FR ARROW BRAIDED
• Patient Outcome(s): Hospitalization