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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM XC; CATHETER, PERIPHERAL, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION JETSTREAM XC; CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 45007
Device Problems Leak/Splash (1354); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/20/2018
Event Type  malfunction  
Event Description
It was reported that the catheter ruptured.A 2.1mm jetstream xc catheter was selected for an atherectomy procedure in a unspecified lesion.Towards the end of the procedure using the full length of the catheter, the catheter expanded and ruptured right at the sheath.Solution spilled out of the ruptured location.The device was removed from the patient.An arteriogram was performed.No further treatment was performed.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a jetstream xc-2.1 atherectomy catheter.The device was visually examined for any shaft damage.Visual examination notice that there were multiple areas of small kinks on the catheter shaft from 77cm to 86cm from the tip.Visual examination noticed that the infusion line had burst proximal the kinks and damage.The location of the burst infusion line was approximately 93cm to 94cm from the tip.The damage that was notice is consistent with sheath interference during the procedure.Pushing, pulling and torqueing of the device could possibly cause the damage that was noticed.The kinks on the shaft causes the fluid to back up inside of the infusion sheath and causes the infusion sheath to burst proximal of the buckling.The device was set-up and functionally tested and the device functioned as designed except for the leaking at the burst infusion line.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
 
Event Description
It was reported that the catheter ruptured.A 2.1mm jetstream xc catheter was selected for an atherectomy procedure in a unspecified lesion.Towards the end of the procedure using the full length of the catheter, the catheter expanded and ruptured right at the sheath.Solution spilled out of the ruptured location.The device was removed from the patient.An arteriogram was performed.No further treatment was performed.There were no patient complications reported.
 
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Brand Name
JETSTREAM XC
Type of Device
CATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8138516
MDR Text Key129501777
Report Number2134265-2018-63560
Device Sequence Number1
Product Code MCW
UDI-Device Identifier08714729889892
UDI-Public08714729889892
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,health
Type of Report Initial,Followup
Report Date 01/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/29/2020
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0022053770
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2018
Date Manufacturer Received12/17/2018
Patient Sequence Number1
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