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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 Problems Break (1069); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/22/2018
Event Type  malfunction  
Event Description
It was reported that the catheter split and leaked.A 2.1mm jetstream xc atherectomy catheter was selected for an atherectomy procedure, for a patient with critical limb ischemia (cli), in the superficial femoral artery (sfa) and the proximal popliteal artery.During the procedure, one pass with blades down mode was successfully performed; however it was noted that the outermost layer of the catheter had split outside the sheath, which located outside the patient, and was leaking the solution of rotaglide/saline.The device was successfully rex'd back out of the lesion and then removed from the patient.The result was good with one pass using this device.The procedure was completed by ballooning the lesion.No patient complications were reported.
 
Event Description
It was reported that the catheter split and leaked.A 2.1mm jetstream xc atherectomy catheter was selected for an atherectomy procedure, for a patient with critical limb ischemia (cli), in the superficial femoral artery (sfa) and the proximal popliteal artery.During the procedure, one pass with blades down mode was successfully performed; however it was noted that the outermost layer of the catheter had split outside the sheath, which located outside the patient, and was leaking the solution of rotaglide/saline.The device was successfully rex'd back out of the lesion and then removed from the patient.The result was good with one pass using this device.The procedure was completed by ballooning the lesion.No patient complications were reported.Device evaluated by mfg: the returned product consisted of a jetstream xc-2.1 atherectomy catheter.The device was visually examined for any shaft damage.Visual examination notice that there were multiple areas of small kinks on the catheter shaft from the tip to 15cm proximal.There was damage on the shaft (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 51.5cm to 53cm from the tip.The damage that was notice is consistent with sheath interference during the procedure.Pushing, pulling and torqueing 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 was set-up and functionally tested and the device functioned as designed except for the leaking at the burst.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
 
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Brand Name
JETSTREAM XC ATHERECTOMY CATHETER
Type of Device
CATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8034662
MDR Text Key126082986
Report Number2134265-2018-62538
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 12/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/21/2019
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0021408380
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2018
Date Manufacturer Received11/15/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age94 YR
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