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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); Difficult to Advance (2920); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/07/2018
Event Type  malfunction  
Event Description
It was reported that the device became entrapped on the wire. A 2. 1mm jetstream xc catheter and a 014 300cm thruway wire were selected for an atherectomy procedure in the superficial femoral artery (sfa). During advancement of the device, there was a lot of resistance although the vessel was opened at the proximal end. The jetstream crumbled like an accordion and became stuck on the wire. The wire was noted to be kinked distal to the tip from all the pushing. It was noted that rota glide was in the saline bag. The catheter and wire were removed together as one system. Once the devices were removed from the patient, the wire was forcefully pulled from the catheter and the wire was thrown away. The procedure was completed with a new device. There were no patient complications and the patient's status is fine. Device evaluated by mfr: returned product consisted of a jetstream xc-2. 1 atherectomy catheter in one piece. Visual inspection of the device revealed no discrepancies. The shaft and the functionality of the device were investigated. Functional analysis was done by completing the set-up procedure per the directions for use (dfu) and the device primed as designed. There were no discrepancies or issues with the functionality of the device; however, there was noticeable damage in the form of buckling/kinks in 3 locations on the shaft. The locations were approximately 15cm to 20cm, 56cm to 67. 5cm and 78. 5cm to 83. 5cm from the tip. The damage on the shaft is consistent with introducer sheath interaction. Pushing, pulling and torquing the device may possibly lead to the damage noticed. There was no guidewire returned with the device. The shaft damage reported was confirmed. Inspection of the remainder of the device, apart from the observed damage, revealed no other 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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORK LIMITED
cork business technology park
model farm road
cork
EI
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key7820176
MDR Text Key118399821
Report Number2134265-2018-60455
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/24/2019
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0021646003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/23/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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