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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 Mechanical Problem (1384); Difficult to Advance (2920); Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2021
Event Type  malfunction  
Manufacturer Narrative
Device eval by mfr: the jetstream device xc-2. 4 was received by boston scientific for analysis. Visual examination showed two kinks located 1cm and 1. 5cm from the tip. There was blood in the aspiration line. The functionality of the device was checked by setting up the product per the ifu. The device primed as designed. The device was activated, and the blades did not spin as designed. The devices motor was heard; however, no tip rotation was noticed. The devices pod was opened to inspect for damage. It was noticed the pinion gear had slipped off the drive shaft. When the gear slides off the shaft and does not contact the motor gear, rotation of the tip would stop. The gear was removed and inspected. Adhesive was present on the gear as designed.
 
Event Description
It was reported that the blades lost rotation. A 2. 4mm jetstream catheter was selected for use to treat peripheral artery disease (pad) in the mid superficial femoral artery (sfa). The target lesion was 60-70% stenosed, mildly tortuous and moderately calcified. The device was advanced through the lesion in both blades down and blades up mode. During treatment of the lesion, significant resistance was noted and the blades stopped spinning. The rotation could not be reactivated. The device was removed and a new jetstream was used to complete the procedure. 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 CORPORATION
model farm road
cork IRELA ND
EI IRELAND
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12780315
MDR Text Key280532239
Report Number2134265-2021-13922
Device Sequence Number1
Product Code MCW
UDI-Device Identifier08714729889922
UDI-Public08714729889922
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0027563417
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received10/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/25/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

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