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

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

Patient Problems Hematoma (1884); Pain (1994); Pseudoaneurysm (2605); Swelling/ Edema (4577)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

Park j.H., et al.(2021).Tctap c-089 pseudoaneurysm of popliteal artery as a delayed complication of jetstream atherectomy.Journal of the american college of cardiology 2021: 77 (14 supplement) p.S194 - s196.Date of event was approximated using month of article submission.

Event Description

It was reported via journal article that six days post atherectomy, a pseudoaneurysm and hematoma were found in the popliteal artery.A 2.4/3.4mm jetstream was selected for use in an atherectomy procedure.The patient was in the supine position, put under general anesthesia, and draped with betadine from umbilicus to both toes.Access was achieved through an ultrasound-guided direct puncture.A 7fr sheath was inserted, and an angiogram was performed revealing a nearly total occlusion in the popliteal artery.A 0.014 inch wire was advanced to the posterior tibial artery supported rubicon catheter.Balloon angioplasty was performed at the right distal superficial femoral artery (sfa), popliteal artery, and posterior tibial artery with a 2.5cm x 220mm balloon.A non-boston scientific embolic protection system was deployed at the right tibio-peroneal trunk.Mechanical atherectomy at the right popliteal artery was performed with the jetstream device.Ablation was performed with the luminal diameter twice and in blades up mode twice.The filter was removed.Drug-coated balloon (dcb) angioplasty was performed with a 6cm x 150mm non-boston scientific dcb.Final angiogram revealed blood flow to the popliteal artery.The device was removed, and hemostasis was observed.After surgery, the ankle-brachial index (abi) improved, and the patient was discharged.Six days after atherectomy, the patient visited the emergency room with calf pain and swelling.The vital signs were stable, and there was no decrease in hemoglobin.Prior to catheterization, pseudoaneurysm and hematoma were found in the popliteal artery by computed tomography (ct) angiogram.During the follow-up after hospitalization, the pain and swelling of the lower extremities worsened, and emergency surgical exploration was performed due to suspected popliteal arterial rupture and compartment syndrome.The patient was in the prone position and put under general anesthesia.A longitudinal incision was made at the popliteal fossa.The popliteal artery was found to be ruptured.The upper and lower parts of the rupture site were clamped.Endarterectomy and patch angioplasty with bovine patch were performed followed by skin wall closure.

• Brand Name: JETSTREAM ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11812006
• MDR Text Key: 250192637
• Report Number: 2134265-2021-05515
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention