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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 Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/01/2019
Event Type  malfunction  
Event Description
It was reported that the infusion line burst.A 2.4mm jetstream xc atherectomy catheter was selected for use in a procedure in the right superficial femoral artery (sfa).Vascular access was obtained via the left femoral artery up and over the bifurcation to treat the right leg using a non-bsc introducer sheath.A non-bsc filterwire was placed in the profunda and a thruway guidewire into the sfa.The jetstream was then used over the thruway wire to treat the lesion.The lesion was successfully treated, and the device was removed from the patient.Upon removal, the physician noticed that the infusion line of the catheter had ruptured approximately 25cm from the distal tip.Aspiration and infusion had not been lost during the procedure.The physician attributed the ruptured infusion line to the filterwire being used in a narrow anatomical space.Another device, same model, was then selected to finish the procedure.The patient experienced no adverse effects and is doing well.
 
Manufacturer Narrative
Device analysis by mfr: the returned product consisted of a jetstream xc 2.4mm atherectomy catheter.Visual examination notice that there was shaft damage in the form of buckling/kinks located in multiple areas from the tip proximal to 15cm.Visual examination noticed that the infusion line had burst damage proximal the buckling/kinks.The location of the damaged infusion line was approximately 60cm to 61cm from the tip.Functional testing showed the device to run as designed.During analysis of the device, a leak was noticed at the burst infusion line.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
 
Event Description
It was reported that the infusion line burst.A 2.4mm jetstream xc atherectomy catheter was selected for use in a procedure in the right superficial femoral artery (sfa).Vascular access was obtained via the left femoral artery up and over the bifurcation to treat the right leg using a non-bsc introducer sheath.A non-bsc filterwire was placed in the profunda and a thruway guidewire into the sfa.The jetstream was then used over the thruway wire to treat the lesion.The lesion was successfully treated, and the device was removed from the patient.Upon removal, the physician noticed that the infusion line of the catheter had ruptured approximately 25cm from the distal tip.Aspiration and infusion had not been lost during the procedure.The physician attributed the ruptured infusion line to the filterwire being used in a narrow anatomical space.Another device, same model, was then selected to finish the procedure.The patient experienced no adverse effects and is doing well.
 
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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 Key9357515
MDR Text Key173484828
Report Number2134265-2019-14199
Device Sequence Number1
Product Code MCW
UDI-Device Identifier08714729889922
UDI-Public08714729889922
Combination Product (y/n)N
PMA/PMN Number
K133023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/11/2021
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0023628450
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2019
Initial Date Manufacturer Received 11/01/2019
Initial Date FDA Received11/21/2019
Supplement Dates Manufacturer Received12/06/2019
Supplement Dates FDA Received12/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ABBOTT NAV6 EMBOLIC PROTECTION SYSTEM; ABBOTT NAV6 EMBOLIC PROTECTION SYSTEM
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