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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)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2022
Event Type  malfunction  
Event Description
It was reported that the infusion line peeled up. A 2. 1mm jetstream xc atherectomy catheter was selected for use in an atherectomy and angioplasty procedure in the 90% stenosed left superficial femoral artery (sfa) and popliteal artery. There was difficulty advancing the device once in the mid sfa of the left lower extremity. The device was slowly advanced in minimum tip mode until it was unable to advance. At this time, it was observed that the outer layer was peeling up. The device was removed using rex mode. The procedure was successfully completed using a ranger drug-coated balloon in the left sfa and a sterling balloon in the popliteal artery. No patient complications were reported.
 
Manufacturer Narrative
Device eval by manufacturer: the device returned to boston scientific consisted of a jetstream xc-2. 1 atherectomy catheter. The baton and electrical connection were cut off the device from the customer site when received. The device was visually examined for any shaft damage. Visual and microscopic examination showed multiple bends and buckling/kinks along the shaft. The device showed a burst infusion sheath on the catheter shaft located 84cm to 87cm from the tip. The device could not be functionally tested due to the baton and electrical connections being cut off. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. The complaint of the device having shaft damage was confirmed.
 
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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 Key13933144
MDR Text Key288098693
Report Number2134265-2022-03531
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0027355794
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

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