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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); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/30/2019
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: 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 buckling/kinks. The location of the damage was 18cm to 70cm from the tip. The damage was in multiple areas along the location. Visual examination noticed that the infusion line had burst proximal the buckling/kinks. The location of the burst infusion line was approximately 70. 5cm to 75. 5cm from the tip. The damage that was notice is consistent with sheath interference during the procedure or by pushing, pulling and torqueing of the device in a tortuous anatomy or a heavily calcified lesion. The device was set-up and functionally tested per the dfu and the device functioned as designed except for the leaking 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 bubbled and popped. A 2. 1mm jetstream atherectomy catheter was selected for an atherectomy procedure in the left distal superficial femoral artery (sfa) at the adductor canal. The catheter was prepped per usual and used in blades down mode for the entire procedure. During the procedure, the catheter was slowly advanced over a 0. 014 thruway guidewire through the occlusion. The catheter advanced until the adductor canal, where it became difficult to advance. As the physician attempted to advance the device, the infusion line of the catheter began to bubble at the entrance to the sheath. A large bubble formed and popped. The catheter was immediately removed from the patient in normal fashion. The procedure was completed with follow up angioplasty and two additional stents placed in the sfa. There were no patient complications.
 
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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
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key8925259
MDR Text Key155354886
Report Number2134265-2019-10145
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,Followup
Report Date 09/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/24/2020
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0023237806
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/23/2019 Patient Sequence Number: 1
Treatment
0.014 THRUWAY GUIDEWIRE
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