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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION JETSTREAM XC ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 45007
Device Problems Entrapment of Device (1212); Mechanical Problem (1384)
Patient Problems Pain (1994); Vascular Dissection (3160)
Event Date 09/23/2021
Event Type  malfunction  
Event Description
It was reported that the catheter became entrapped on the guidewire and the procedure was cancelled. A 2. 1mm jetstream xc catheter and a thruway guidewire were selected for use in the superficial femoral artery (sfa). The sfa was a severely tortuous and minimally calcified, 100% chronic total occlusion (cto). Vascular access was obtained via safari technique (subintimal arterial flossing with antegrade-retrograde intervention). A moderate to large subintimal plane at the proximal origin of the common femoral artery and sfa occurred prior to the insertion of this 0. 014 thruway guide wire. The jetstream was advanced over the guidewire and used with 30 second run times and 20 second rex times. The lesion was treated with blades down using two passes. Expandable blades were engaged and there where periods where the audible revs slowed and it was decided that a sub intimal plane was accessed and blades where disengaged. This occurred in approximately 3 areas, but one was prolonged regarding blades up engagement. The catheter was then attempted to be removed but was unsuccessful as it became entrapped on the thruway guidewire. The catheter and guidewire were removed through the formal sheath as one unit. The jetstream atherectomy procedure was successfully completed but access to the target vessel was lost due to the entire atherectomy system (jetstream catheter and thruway) needing to be removed as one system. Vessel access was unable to be re established due to the loss of wire access and the large subintimal plane at the flush occlusion at the proximal end of the vessel. The true lumen of the vessel was unable to be re accessed to complete the procedure and maintain patency of the vessel. It was noted that the patient presented with back issues, the back pain was a pre procedural issue for the patient and had no influence from the jetstream device. There were no patient complications and the patient was stable after the procedure. A bypass procedure was planned at a later date.
 
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Brand NameJETSTREAM XC ATHERECTOMY CATHETER
Type of DeviceCATHETER, 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 Key12624012
MDR Text Key276149329
Report Number2134265-2021-12783
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0026505048
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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