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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 Difficult to Advance (2920); Material Deformation (2976); Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/08/2021
Event Type  malfunction  
Manufacturer Narrative
Device eval by mfr: the jetstream device xc-2. 4 was received by boston scientific for analysis. The shaft and the remainder of the device was inspected for damage. Visual examination showed multiple areas of shaft damage located 1cm from the tip to 16cm from the tip. The infusion line showed some ballooning damage located 77. 5cm to 79cm from the tip. The functionality of the device was checked by setting up the product per the instructions for use. A. 014 test thruway guidewire was inserted into the device with no hesitations or restrictions. The device primed as designed. The device was activated, and the blades did spin as designed. The device ran for a period of 1 minute in the blades down mode. The device was put into the blades up mode and ran for a period of 30 seconds and the blades stopped spinning. The motor was heard and continued to spin. The devices pod was opened to inspect for damage. It was noticed the pinion gear had slipped off the drive shaft. When the pinion gear slides off the shaft and does not contact the motor gear, rotation of the blades would stop. The gear was slid back onto the shaft and reengaged with the motor gear and the device was run again. The devices blades did not rotate as the gear was spinning on the shaft.
 
Event Description
Reportable based on device analysis completed on 10nov2021. A 2. 4mm jetstream xc catheter was selected for use to treat peripheral artery disease (pad). Pedal access was used to reach the target lesion. As the device was advanced, while inside of the patient, there was difficulty/resistance with advancement. Kinking, buckling, and some malformations were noted on the shaft, and it could not be loaded back onto the guidewire after it was removed from the patient. The procedure was completed and there were no patient complications reported. However, device analysis revealed the blades stopped spinning.
 
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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
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12923232
MDR Text Key281658365
Report Number2134265-2021-14604
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 02/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0027563421
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/27/2022
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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