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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 Problem Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/06/2019
Event Type  malfunction  
Event Description
It was reported that the catheter became stuck on the wire.A 2.4mm jetstream xc atherectomy catheter was selected for a procedure.During the procedure, the catheter became stuck on the non-bsc guidewire.Everything was removed together.The procedure was completed with another of the same device.There were no patient complications and the patient was stable post procedure.
 
Event Description
It was reported that the catheter became stuck on the wire.A 2.4mm jetstream xc atherectomy catheter was selected for a procedure.During the procedure, the catheter became stuck on the non-bsc guidewire.Everything was removed together.The procedure was completed with another of the same device.There were no patient complications and the patient was stable post procedure.
 
Manufacturer Narrative
Updated device evaluated by mfr: returned product consisted of a jetstream xc-2.4 atherectomy catheter.The guidewire was returned stuck in the device.The device and the catheter shaft were analyzed for damage.The catheter shaft showed no damage.It was noticed that the guidewire which was stuck in the device, showed damage in the form of the coils on the tip coming unraveled.This is consistent with the device being run too far distal and running over the coils.The device was run so far distal over the wire that the bushing became occluded with the coils from the tip and contributed to the guidewire sticking issues the customer experienced.The device was connected to the jetstream console and was functionally tested for rotation issues.The device ran as designed.Inspection of the remainder of the device, revealed no damage or irregularities.
 
Event Description
It was reported that the catheter became stuck on the wire.A 2.4mm jetstream xc atherectomy catheter was selected for a procedure.During the procedure, the catheter became stuck on the non-bsc guidewire.Everything was removed together.The procedure was completed with another of the same device.There were no patient complications and the patient was stable post procedure.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a jetstream xc-2.4 atherectomy catheter.The guidewire was returned stuck in the device.The device and the catheter shaft were analyzed for damage.The catheter shaft showed no damage.It was noticed that the guidewire, which was stuck in the device, showed damage in the form of the coils on the tip coming unraveled.This was consistent with the device being run too far distal and running over the coils.The device was connected to the jetstream console and was functionally tested for rotation issues.The device ran as designed.Inspection of the remainder of the device, revealed no damage or irregularities.
 
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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 Key9341803
MDR Text Key169135376
Report Number2134265-2019-14038
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,Followup
Report Date 12/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2019
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 Number0024474606
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2019
Date Manufacturer Received12/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ABBOTT NAV6FILTER GUIDEWIRE; ABBOTT NAV6FILTER GUIDEWIRE; ABBOTT NAV6FILTER GUIDEWIRE
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