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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK JETSTREAM® XC ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY

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BOSTON SCIENTIFIC - CORK JETSTREAM® XC ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 112264-001
Device Problems Difficult to Advance (2920); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/01/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device evaluated by manufacturer: returned product consisted of a jetstream xc-2. 1 atherectomy catheter. The device was visually examined for any shaft damage. Visual examination showed damage on the shaft. It was noticed that the catheter shaft was buckled in 1 place proximal the tip. The buckled area was approximately 84cm from the tip and functional testing is not possible due to the damage on this device. The buckling causes the fluid to back up inside of the infusion sheath and cause the infusion sheath to burst proximal of the buckling. This was the case on this device. The damaged area of the infusion sheath was approximately 88cm from the tip. When this happens the device leaks fluid from the damaged area and the performance of the device diminishes. Buckling is usually cause by the device being pushed, pulled and torqued in the introducer sheath during the procedure. The most probable root cause is operational context as device performance was limited due to anatomical procedural factors. (b)(4).
 
Event Description
Reportable based on the product analysis completed on september 21, 2017. It was reported difficulty advancing and the infusion line was deformed. A 2. 1mm jetstream xc atherectomy catheter was selected for use along with a along with non bsc sheath. The target lesion was located in the chronic total occlusion (cto) mid to distal superficial femoral artery (sfa). The jetstream device was advanced through the sheath into the lesion, but was unable to advance any further. Visibility was lost and the outside of the outer coating/sheath was noted to be bunched up. The device was removed from the patient and the procedure was completed with balloon angioplasty. No patient complications were reported and the patient status was fine post procedure. However, the returned product analysis revealed a burst infusion sheath.
 
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Brand NameJETSTREAM® XC ATHERECTOMY CATHETER
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI
Manufacturer (Section G)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6941870
MDR Text Key90234964
Report Number2134265-2017-09915
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130637
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/25/2019
Device Model Number112264-001
Device Catalogue NumberPV31300
Device Lot Number0020557156
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/11/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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