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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 Problem No Consequences Or Impact To Patient (2199)
Event Date 10/08/2019
Event Type  malfunction  
Event Description
It was reported that the catheter became stuck on the wire.A 2.1mm jetstream xc atherectomy catheter was selected for an atherectomy procedure in the heavily calcified mid superficial femoral artery (sfa).During the procedure, the jetstream catheter was advanced over a non-bsc guidewire.The first pass was performed with blades down successfully.During the second pass, the catheter stopped working and became stuck on the on the guidewire in the middle of the highly calcified lesion.The jetstream catheter and the guidewire were removed from the patient together.The procedure was completed with a different device.There were no patient complications.
 
Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of a jetstream xc-2.1 atherectomy catheter with a guidewire stuck inside the device.The shaft and the remainder of the device were inspected for damage.Visual examination showed 2 kinks located 1cm from the tip and the other at the strain relief of the device.The guidewire was pulled from the device with a restriction due to the kinks.Functional analysis was done by completing the setup procedure.Test results showed that device blades did not rotate due to the shaft was separated inside the pod.Inspection of the remainder of the device revealed no other damage or irregularities.
 
Event Description
It was reported that the catheter became stuck on the wire.A 2.1mm jetstream xc atherectomy catheter was selected for an atherectomy procedure in the heavily calcified mid superficial femoral artery (sfa).During the procedure, the jetstream catheter was advanced over a non-bsc guidewire.The first pass was performed with blades down successfully.During the second pass, the catheter stopped working and became stuck on the on the guidewire in the middle of the highly calcified lesion.The jetstream catheter and the guidewire were removed from the patient together.The procedure was completed with a different device.There were no patient complications.
 
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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 Key9244463
MDR Text Key164692190
Report Number2134265-2019-13029
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
PMA/PMN Number
K133023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0024050839
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2019
Date Manufacturer Received11/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ABBOTT SPARTACORE GUIDEWIRE; ABBOTT SPARTACORE GUIDEWIRE
Patient Age75 YR
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