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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 Mechanical Problem (1384); Suction Problem (2170)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/16/2018
Event Type  malfunction  
Event Description
It was reported that the blades would not go down and the device was not aspirating successfully. A 2. 1mm jetstream xc catheter was selected for use for an atherectomy procedure. During procedure, while the physician attempted to go into rex mode, it was noted that the blades could not be retracted into blades down mode. Also, the device was not aspirating successfully. The blades were rotating on and off. The system was then shut down and the catheter was removed. The procedure was completed with another device. There were no patient complications reported.
 
Event Description
It was reported that the blades would not go down and the device was not aspirating successfully. A 2. 1mm jetstream xc catheter was selected for use for an atherectomy procedure. During procedure, while the physician attempted to go into rex mode, it was noted that the blades could not be retracted into blades down mode. Also, the device was not aspirating successfully. The blades were rotating on and off. The system was then shut down and the catheter was removed. The procedure was completed with another device. There were no patient complications reported. Device evaluated by mfr: visual inspection showed 2 kinks on the device. The first kink was located 48cm from the tip and the 2nd kink which was much more severe and was located at 62cm from the tip. Functional testing revealed the device primed and did not function as design. The blades did not rotate. The shaft was dissected at the most severe kink and it was noticed that the drive coil was kinked a damaged. The coils started to unravel. With this damage the rotation of the blades would not be possible. This damage may be caused by pushing, pulling and torqueing of the device during the procedure. Since the device would not function the shaft was further dissected to inspect for any clot burden that may cause an aspiration issue. No occlusion was found during this analysis.
 
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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
MDR Report Key8117595
MDR Text Key128868374
Report Number2134265-2018-63296
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
PMA/PMN Number
K130637
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/22/2019
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0020674068
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2018
Is This a Reprocessed and Reused Single-Use Device? No

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