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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 Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/17/2019
Event Type  malfunction  
Event Description
It was reported that outer sheath peeled.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.
 
Event Description
It was reported that outer sheath peeled.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.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a jetstream xc-2.1 atherectomy catheter.The shaft and the remainder of the device was inspected for damage.Visual examination showed 2 kinks and buckling.The kinks were located 85.5cm and 88cm from the tip.The buckling was located 1.5cm from the tip.The functionality of the device was checked by setting up the product per the directions for use.The device primed, and the device functioned as designed.The kinks and the buckling of the shaft are consistent with interaction with another device such as an introducer sheath.Pushing, pulling and torqueing the device may cause this kind of damage.The peeling back of the of the outer sheath the customer described may have been the buckling notice at the tip of 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 Name
JETSTREAM XC
Type of Device
CATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8310675
MDR Text Key135177023
Report Number2134265-2019-00816
Device Sequence Number1
Product Code MCW
UDI-Device Identifier08714729889892
UDI-Public08714729889892
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 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 Health Professional
Device Expiration Date08/08/2020
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0022624463
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2019
Date Manufacturer Received02/08/2019
Patient Sequence Number1
Treatment
SHEATH: 7F COOK; SHEATH: 7F COOK; SHEATH: 7F COOK
Patient Age66 YR
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