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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM XC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION JETSTREAM XC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 45007
Device Problem Suction Problem (2170)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2021
Event Type  malfunction  
Event Description
It was reported that a loss of aspiration occurred.The target lesion was located in the superficial femoral artery (sfa).A 2.1mm jetstream xc atherectomy catheter was selected for an atherectomy procedure.A lot of thrombotic material was present.The catheter stopped sucking and was removed from the patient.The procedure was successfully completed with another 2.1mm jetstream catheter.There were no patient complications and the patient's status was fine.
 
Manufacturer Narrative
Date of event: no date provided, used the first date in the month of the aware date.
 
Event Description
It was reported that a loss of aspiration occurred.The target lesion was located in the superficial femoral artery (sfa).A 2.1mm jetstream xc atherectomy catheter was selected for an atherectomy procedure.A lot of thrombotic material was present.The catheter stopped sucking and was removed from the patient.The procedure was successfully completed with another 2.1mm jetstream catheter.There were no patient complications and the patient's status was fine.
 
Manufacturer Narrative
B3.Date of event: no date provided, used the first date in the month of the aware date.Device evaluated by mfr: returned product consisted of a jetstream xc-2.1 atherectomy catheter.The device was visually examined for any shaft damage and the functional testing of the device was completed.The device showed no damage.Functional analysis was done by completing the setup procedure per the instructions for use.Aspiration testing of the device was done per the test procedure.The device is tested by using a 100ml beaker of water.The devices tip is submerged in a beaker of fluid and the device is run for a period of 1 minute.The final milliliters of fluid that the beaker shows after the 1minute run time is subtracted from the starting milliliters and the final number is the total that was aspirated (100ml-2ml=98ml).The minimum amount of fluid that is aspirated per the test procedure specification sheet is 30ml per minute and the maximum is 56ml per minute.Test results showed that this device did not perform as designed per the test procedure specification sheet withdrawing 2ml of fluid in the 1minute time frame.Inspection of the remainder of the device revealed no damage or irregularities.
 
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Brand Name
JETSTREAM XC ATHERECTOMY CATHETER
Type of Device
CATHETER, 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 Key13079148
MDR Text Key282727012
Report Number2134265-2021-16098
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/09/2023
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0027799557
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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