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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Embolism (1829); Vascular Dissection (3160)
Event Date 05/08/2019
Event Type  Injury  
Manufacturer Narrative
Initial reporter facility name: (b)(6).
 
Event Description
It was reported that a distal embolization and grade c dissection occurred.The patient was enrolled in the jetstream (b)(6) study with the patient identifier of (b)(6).As part of the study, the patient underwent treatment on (b)(6) 2019.The target lesion was located in the left mid to distal superficial femoral artery (sfa) and was 80% occluded, a reference vessel diameter of 4 mm, length of 150 mm and classified as a tasc ii a lesion.The target lesion was treated with a jetstream pv atherectomy system console and a 2.1mm jetstream xc atherectomy catheter and there was 40% residual stenosis.Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed, with 20% final residual stenosis.During the index procedure, distal embolization of the target lesion was noted.The location of embolization was found to be 2-5 cm away from the lower margin of the target lesion with no symptoms.Post embolization, blood flow was slow.The embolization was treated with angiography and endovascular intervention; percutaneous transluminal angioplasty (pta) and stenting.The embolization was considered recovered/resolved on the same day.Also during this procedure, a grade c dissection of the target lesion was noted post pta.No action was taken to treat this event.At the time of reporting, the event was recovering/ resolving.No further complications were reported.
 
Manufacturer Narrative
Initial reporter facility name: (b)(6) hospital.
 
Event Description
It was reported that a distal embolization and grade c dissection occurred.The patient was enrolled in the jetstream china study with the patient identifier of (b)(6).As part of the study, the patient underwent treatment on (b)(6) 2019.The target lesion was located in the left mid to distal superficial femoral artery (sfa) and was 80% occluded, a reference vessel diameter of 4 mm, length of 150 mm and classified as a tasc ii a lesion.The target lesion was treated with a jetstream pv atherectomy system console and a 2.1mm jetstream xc atherectomy catheter and there was 40% residual stenosis.Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed, with 20% final residual stenosis.During the index procedure, distal embolization of the target lesion was noted.The location of embolization was found to be 2-5 cm away from the lower margin of the target lesion with no symptoms.Post embolization, blood flow was slow.The embolization was treated with angiography and endovascular intervention; percutaneous transluminal angioplasty (pta) and stenting.The embolization was considered recovered/resolved on the same day.Also during this procedure, a grade c dissection of the target lesion was noted post pta.No action was taken to treat this event.At the time of reporting, the event was recovering/ resolving.No further complications were reported.It was further reported that the dissection occurred after pta, during the jetstream procedure, and the physician did not take action for this issue.No device issues were noted with the performance of the jetstream catheter, or the console, during the procedure.The physician believed that the distal embolization was caused by some soft thrombotic components in the lesion that easily peeled off when using jetstream.The embolism was successfully treated with the angiography and pta/stenting.The patient was returned safely to the ward after the procedure.
 
Event Description
It was reported that a distal embolization and grade c dissection occurred.The patient was enrolled in the jetstream china study with the patient identifier of (b)(6).As part of the study, the patient underwent treatment on (b)(6) 2019.The target lesion was located in the left mid to distal superficial femoral artery (sfa) and was 80% occluded, a reference vessel diameter of 4 mm, length of 150 mm and classified as a tasc ii a lesion.The target lesion was treated with a jetstream pv atherectomy system console and a 2.1mm jetstream xc atherectomy catheter and there was 40% residual stenosis.Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed, with 20% final residual stenosis.During the index procedure, distal embolization of the target lesion was noted.The location of embolization was found to be 2-5 cm away from the lower margin of the target lesion with no symptoms.Post embolization, blood flow was slow.The embolization was treated with angiography and endovascular intervention; percutaneous transluminal angioplasty (pta) and stenting.The embolization was considered recovered/resolved on the same day.Also during this procedure, a grade c dissection of the target lesion was noted post pta.No action was taken to treat this event.At the time of reporting, the event was recovering/ resolving.No further complications were reported.It was further reported that the dissection occurred after pta, during the jetstream procedure, and the physician did not take action for this issue.No device issues were noted with the performance of the jetstream catheter, or the console, during the procedure.The physician believed that the distal embolization was caused by some soft thrombotic components in the lesion that easily peeled off when using jetstream.The embolism was successfully treated with the angiography and pta/stenting.The patient was returned safely to the ward after the procedure.It was further reported that this jetstream xc catheter was not related to the grade c dissection.The dissection occurred after pta treatment and was not contributed by the jetstream xc catheter.
 
Manufacturer Narrative
Initial reporter facility name: (b)(6).
 
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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 Key8667002
MDR Text Key146937123
Report Number2134265-2019-06307
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,Followup
Report Date 09/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/14/2019
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0021375755
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/13/2019
Initial Date FDA Received06/04/2019
Supplement Dates Manufacturer Received06/21/2019
09/13/2019
Supplement Dates FDA Received06/24/2019
09/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age71 YR
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