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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 Entrapment of Device (1212); Material Twisted/Bent (2981)
Patient Problem Thrombosis (2100)
Event Date 12/10/2018
Event Type  Injury  
Event Description
It was reported that the device stuck on the wire and thrombosis occurred.A 2.1mm jetstream xc atherectomy catheter was selected for use in an atherectomy procedure.During the procedure inside the patient's body, the device crossed.Upon finishing the procedure, the device stuck a bit and some wire was lost as the device was pulled out and it was noted that the catheter partly wrinkled on itself at the tip.The patient was hospitalized due to some clot that formed in the previously placed stent.No further patient complications were reported.
 
Event Description
It was reported that the device stuck on the wire and thrombosis occurred.A 2.1mm jetstream xc atherectomy catheter was selected for use in an atherectomy procedure.During the procedure inside the patient's body, the device crossed.Upon finishing the procedure, the device stuck a bit and some wire was lost as the device was pulled out and it was noted that the catheter partly wrinkled on itself at the tip.The patient was hospitalized due to some clot that formed in the previously placed stent.No further patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a jetstream xc-2.1 atherectomy catheter.No guidewire was returned or reported of the make.The device and the catheter shaft were analyzed for damage.Visual analysis showed buckling/kinking approximately 2cm and 4cm from the tip.Functionality was completed by connecting the device to the jetstream console.The device functioned as designed.A.014 thruway guidewire was inserted into the device and transcended through the device with no hesitations or restrictions.Inspection of the remainder of the device, revealed no damage or irregularities.
 
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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 Key8171088
MDR Text Key130553145
Report Number2134265-2018-64408
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 Received12/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/05/2020
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0022756971
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2018
Date Manufacturer Received01/02/2019
Patient Sequence Number1
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