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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 Embolism (1829)
Event Date 09/27/2018
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the catheter became stuck on the wire and some distal embolization occurred. A 2. 4mm jetstream xc atherectomy catheter was selected for an atherectomy procedure in the superficial femoral artery (sfa) and the popliteal artery. During the procedure, the physician inserted a non-bsc filterwire and also a non-bsc guidewire. Then the jetstream device was placed. After some minutes of atherectomy, the jetstream catheter became stuck with the guidewire. They had to remove the jetstream catheter from the patient with an open filter. Some distal embolization occurred. No other patient complications were reported. Device evaluated by mfr: the returned product consisted of a jetstream xc-2. 4 atherectomy catheter with a filter wire stuck in the device. The device and the catheter shaft were analyzed for damage. Visual analysis showed that the device presented no damage. The device tip was disconnected from the shaft. The bushing inside of the tip showed that the device had peeled the coating off during the procedure and caused the bushing to occlude with coating and seize the wire in the device. Functionality was completed by connecting the device to the jetstream console. The device ran as designed with no issues or errors. Inspection of the remainder of the device, revealed no damage or irregularities. It was noticed per the customers returned statement that the guidewire used during the procedure was a non-bsc filter wire. This wire is not on the compatible guidewire list.
 
Manufacturer Narrative
Age at time of event:18 years or older. (b)(6).
 
Event Description
It was reported that the catheter became stuck on the wire and some distal embolization occurred. A 2. 4mm jetstream xc atherectomy catheter was selected for an atherectomy procedure in the superficial femoral artery (sfa) and the popliteal artery. During the procedure, the physician inserted a non-bsc filterwire and also a non-bsc guidewire. Then the jetstream device was placed. After some minutes of atherectomy, the jetstream catheter became stuck with the guidewire. They had to remove the jetstream catheter from the patient with an open filter. Some distal embolization occurred. No other patient complications were reported. Device evaluated by mfr: the returned product consisted of a jetstream xc-2. 4 atherectomy catheter with a filter wire stuck in the device. The device and the catheter shaft were analyzed for damage. Visual analysis showed that the device presented no damage. The device tip was disconnected from the shaft. The bushing inside of the tip showed that the device had peeled the coating off during the procedure and caused the bushing to occlude with coating and seize the wire in the device. Functionality was completed by connecting the device to the jetstream console. The device ran as designed with no issues or errors. Inspection of the remainder of the device, revealed no damage or irregularities. It was noticed per the customers returned statement that the guidewire used during the procedure was a non-bsc filter wire. This wire is not on the compatible guidewire list. It was further reported that a special catheter was used to remove the embolism and the lesion was dilated with a below the knee (btk) balloon. The patient was noted to be fine post procedure.
 
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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 Key7979746
MDR Text Key124162423
Report Number2134265-2018-62054
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 11/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/03/2020
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0022078110
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/18/2018 Patient Sequence Number: 1
Treatment
MEDTRONIC SPIDER FILTERWIRE; MEDTRONIC SPIDER FILTERWIRE; MEDTRONIC SPIDER FILTERWIRE; MEDTRONIC SPIDER GUIDEWIRE; MEDTRONIC SPIDER FILTERWIRE; MEDTRONIC SPIDER GUIDEWIRE
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