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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 Display or Visual Feedback Problem (1184); Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/12/2019
Event Type  malfunction  
Event Description
It was reported that a loss of rotation occurred.A jetstream xc atherectomy catheter was selected for an atherectomy procedure in a femoropopliteal stent obstruction in the left leg.During the procedure inside the patient, the catheter tip appeared to be damaged and stopped rotating after three minutes.A bubble error message displayed and air was seen in the catheter.No air was introduced into the patient.The catheter was purged three times and stopped tree times.The procedure was completed with a different device.There were no patient complications and the patient's status was well.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a jetstream xc-2.4 atherectomy catheter.The shaft and the remainder of the device were inspected for damage.Visual examination showed damage in the form of kink/buckling located 1.3cm from the tip.The distal end of the device looked consistent with handling issues and possibly interference issues with another device.The functionality of the device was checked by setting up the product per the directions for use (dfu).The device primed and ran as designed.The device was run for a period of 3 minutes with no errors or issues.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.
 
Event Description
It was reported that a loss of rotation occurred.A jetstream xc atherectomy catheter was selected for an atherectomy procedure in a femoropopliteal stent obstruction in the left leg.During the procedure inside the patient, the catheter tip appeared to be damaged and stopped rotating after three minutes.A bubble error message displayed and air was seen in the catheter.No air was introduced into the patient.The catheter was purged three times and stopped tree times.The procedure was completed with a different device.There were no patient complications and the patient's status was well.
 
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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 Key8379201
MDR Text Key137444002
Report Number2134265-2019-01815
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 03/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/27/2020
Device Model Number45007
Device Catalogue Number45007
Device Lot Number22855923
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2019
Date Manufacturer Received03/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age57 YR
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