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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 Problems Entrapment of Device (1212); Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/26/2021
Event Type  malfunction  
Event Description
It was reported catheter was stuck and no longer functional.A 2.4mm jetstream xc atherectomy catheter was selected for use in a rotational atherectomy treatment procedure.The jetstream catheter was loaded over a thruway guidewire to the target lesion.During atherectomy, the catheter stopped midway in the calcified lesion.The catheter did not advance or retreat and was blocked.The catheter was removed from the patient and was no longer functional.The procedure was completed using balloon dilation without any problems.
 
Event Description
It was reported catheter was stuck and no longer functional.A 2.4mm jetstream xc atherectomy catheter was selected for use in a rotational atherectomy treatment procedure.The jetstream catheter was loaded over a thruway guidewire to the target lesion.During atherectomy, the catheter stopped midway in the calcified lesion.The catheter did not advance or retreat and was blocked.The catheter was removed from the patient and was no longer functional.The procedure was completed using balloon dilation without any problems.
 
Manufacturer Narrative
Device/media analysis: the jetstream xc-2.4 device was received by boston scientific for analysis.The guidewire was not returned in or with the device.The shaft and the remainder of the device were inspected for damage.Visual examination showed no shaft damage.The functionality of the device was checked by setting up the product per the instructions for use (ifu).A.014 test thruway guidewire was inserted into the device and transcended through the lumen with no issues.The device primed as designed.The device was activated, and the blades did not spin.The devices motor was heard; however, no tip rotation was observed.The devices control pod was opened to inspect for damage.It was noticed the pinion gear moved along the driveshaft and was not in contact with the motor gear.When the pinion gear slides off the shaft and does not contact the motor gear, rotation of the tip will stop.The presence of adhesive on the pinion gear was verified.The gear was slid back on the shaft and the device was activated.The device ran with the blades spinning for 2 minutes, with no issues of the gear moving off the shaft.Device analysis determined the condition of the returned device was consistent with the reported information of blades not spinning.The complaint was not confirmed for guidewire sticking issues.
 
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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
cork IRELA ND
EI   IRELAND
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12961619
MDR Text Key281991750
Report Number2134265-2021-15516
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeSZ
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 02/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/24/2021
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0025095930
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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