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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 Break (1069); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/26/2018
Event Type  malfunction  
Event Description
It was reported that the device partially separated. A 2. 4mm jetstream xc catheter was selected for use for a patient procedure in the common femoral artery. The physician made one pass in blades down and then noticed some resistance advancing the catheter. The catheter was then removed and it was then noticed that, distal to the blades, the catheter seemed to have snapped in half without completely breaking apart. The physician decided that the anatomy of the iliac may have contributed to the device issues and decided not to continue any treatment. The patient will be referred to another physician for a surgical procedure due to anatomical challenge. No patient complications were reported. Device evaluated by mfr: returned product consisted of a jetstream xc-2. 4 atherectomy catheter. The device was visually examined for any shaft damage. Visual examination showed that the devices power and baton were severed from the device. It was notice that there were multiple areas of small kinks on the catheter shaft from the tip to 11cm proximal. There was damage on the shaft damage (aspiration sheath buckled) at 1. 3cm from the tip. Visual examination noticed that the infusion line had burst proximal the kinks and damage. The location of the burst infusion line was approximately 13. 5 to 15cm from the tip. The damage that was noticed is consistent with sheath interference during the procedure. Pushing, pulling and torquing of the device could possibly cause the damage that was noticed. The buckling/kinks on the shaft causes the fluid to back up inside of the infusion sheath and causes the infusion sheath to burst proximal of the buckling. The device could not be set-up and functionally tested due to the baton and the power cords being severed from the device. There was no drive shaft break noticed on the device. 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 Key7974827
MDR Text Key124549953
Report Number2134265-2018-62005
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 10/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/10/2020
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0022107274
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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