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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 Problem Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/07/2018
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that the catheter became stuck on the wire. A 2. 4mm jetstream xc atherectomy catheter and a thruway guidewire were selected for an atherectomy procedure in the left superficial femoral artery (sfa). During removal of the devices after the atherectomy procedure, the catheter got stuck on the guidewire. The catheter and guidewire were removed all together as one from the patient. Another guidewire was used and the lesion was ballooned. There were no patient complications and the patient's status is fine.
 
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that the catheter became stuck on the wire. A 2. 4mm jetstream xc atherectomy catheter and a thruway guidewire were selected for an atherectomy procedure in the left superficial femoral artery (sfa). During removal of the devices after the atherectomy procedure, the catheter got stuck on the guidewire. The catheter and guidewire were removed all together as one from the patient. Another guidewire was used and the lesion was ballooned. There were no patient complications and the patient's status is fine. It was further reported that the thruway wire was not reprocessed or resterilized. Device evaluated by mfr: returned product consisted of a jetstream xc-2. 4 atherectomy catheter with a. 014 thruway wire stuck in the device. The device and the catheter shaft were analyzed for damage. The device showed multiple bends on the shaft. The guidewire was stuck in the device. The wire was pulled from the device with some restriction. The restriction that was felt was most likely due from the multiple bends on the shaft causing friction on the wire when removing. 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, apart from the observed damage revealed no damage or irregularities.
 
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Brand NameJETSTREAM XC
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8116154
MDR Text Key128805956
Report Number2134265-2018-63305
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,health
Type of Report Initial,Followup
Report Date 12/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/15/2020
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0022657768
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/29/2018
Is This a Reprocessed and Reused Single-Use Device? No

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