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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 Mechanical Problem (1384); Difficult to Advance (2920); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/17/2019
Event Type  malfunction  
Event Description
It was reported that loss of rotation occurred. Two 2. 1mm jetstream xc catheters were selected for an atherectomy procedure in the occluded superficial femoral artery. The occluded stent was pre-dilated with an unspecified 2. 0 balloon. The first jetstream made it half way through the stent when it started to slow down. It was difficult to push the device outside the patient. The device kinked outside the patient. The device was removed. Subsequently, the lesion was pre-dilated with an unspecified 4. 0 balloon. One pass was made with the second jetstream device with blades down, rex'd back and one pass with blades up, rex up. It was noted during the second pass blades up, that the outer coating of the catheter inside the patient, started to peel back. The device was not moving and the outer sheath peeled back. Rotaglide and a saline bag were used. The device was removed from the patient. The procedure was completed with a different device. No patient complications were reported and the patient's status is fine.
 
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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 Key8310791
MDR Text Key135180187
Report Number2134265-2019-00817
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130637
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/04/2020
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0022337238
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/05/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/06/2019 Patient Sequence Number: 1
Treatment
SHEATH: 7F COOK
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