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

Model Number 45007

Device Problem Mechanical Problem (1384)

Patient Problems Hematoma (1884); Pain (1994); Perforation of Vessels (2135); Cardiac Tamponade (2226); Blood Loss (2597); Vascular Dissection (3160); No Code Available (3191)

Event Date 09/17/2020

Event Type  Injury  

Event Description

It was reported that the device stalled and also caused perforation, dissection, tamponade, hematoma, and blood loss.A jetstream xc catheter, 2.4mm was selected for use to treat 70% stenosed atherosclerosis in the moderately calcified and mildly tortuous popliteal artery.During the procedure, after the device was run for one minute and thirty seconds at 0.5 mm/second, treating a small eccentric plaque lesion, the device stopped working.The device was removed and it was discovered that the vessel was perforated with a large extravasation and required a non-bsc covered stent be placed to contain the bleeding.The cardiac tamponade was treated by using a 5x100 sterling device.This event caused a drop in blood pressure, intramuscular blood loss, pain and hematoma.Post procedure, patient was reported as stable.The issue was ongoing, and the patient was admitted to the hospital beyond the standard of care.

Event Description

It was reported that the device caused perforation, dissection, tamponade, hematoma, and blood loss.A jetstream xc catheter, 2.4mm was selected for use to treat atherosclerosis in the popliteal artery.During the procedure, after the device was run for one minute and thirty seconds treating a small eccentric plaque lesion the device stopped working.The device was removed and it was discovered that the vessel was perforated with a large extravasation and required a non-bsc covered stent be placed to contain the bleeding.The cardiac tamponade was treated by using a 5x100 sterling device.This event caused low blood pressure, intramuscular blood loss, pain and hematoma.Post procedure, patient was reported as stable.It was further reported that the cause of the tamponade was vessel rupture due to the jetstream catheter eroding the vessel wall.Due to the vessel perforation, vascular balloon tamponade was performed via balloon angioplasty inflation over the perforation for five minutes to occlude flow and limit vessel bleeding into the popliteal fossa.

• 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: 10567877
• MDR Text Key: 207962544
• Report Number: 2134265-2020-13114
• 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: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2022
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0025252280
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2020
• Patient Sequence Number: 1
• Treatment: BAREWIRE 315CM; BAREWIRE 315CM; NAV6 4-7MM FILTER; NAV6 4-7MM FILTER; BAREWIRE 315CM; NAV6 4-7MM FILTER
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 75 YR