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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 Remove (1528); Detachment of Device or Device Component (2907); Difficult to Advance (2920); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/31/2022
Event Type  malfunction  
Event Description
It was reported that a separation occurred at the catheter tip. A 2. 1mm jetstream xc catheter was selected to treat claudication in the superficial femoral artery and popliteal artery. The target lesion was severely calcified and 100% stenosed. Access to the lesion was obtained through the anterior tibial artery using a 7 french sheath. When the catheter was introduced into the patient, it was met with resistance causing it to kink at the mid-shaft. The catheter was removed from the patient and testing confirmed that it was functioning as intended. The catheter was reinserted using retrograde approach through the femoral artery using a 7french x 45cm destination sheath. While advancing, it was met with resistance at the popliteal artery causing the blades to stop spinning. There was difficulty removing the device so the catheter and the 0. 014 thruway guidewire were removed together. Inspection of the device showed that the blade portion at the tip of the catheter had separated but not fully detached. The procedure was completed with balloon angioplasty. There were no patient complications reported.
 
Manufacturer Narrative
Initial reporter address 1: (b)(6).
 
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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
cork IRELA ND
EI IRELAND
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13590552
MDR Text Key286048064
Report Number2134265-2022-01454
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 02/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0028267274
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/26/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

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