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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 09/05/2023
Event Type  malfunction  
Event Description
It was reported that there was a loss of aspiration.A 2.1mm jetstream xc atherectomy catheter was selected for use in an atherectomy procedure.During the procedure, while milling through the lesion, the catheter lost its suction.Even after the catheter was flushed, it did not suck properly again.The procedure was completed using another jetstream catheter.No patient complications were reported.
 
Manufacturer Narrative
Correction to h10 device eval by manufacturer - rotation did function as designed.Device eval by manufacturer: 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 a buckled/kinked shaft located 1cm from the tip.There was blood in the device.Functional analysis was performed, and the rotation of the device functioned as designed.Aspiration testing of the device was performed, and the device performed as designed.Inspection of the remainder of the device revealed no damage or irregularities.The complaint was not confirmed for the reported evacuation failure.
 
Event Description
It was reported that there was a loss of aspiration.A 2.1mm jetstream xc atherectomy catheter was selected for use in an atherectomy procedure.During the procedure, while milling through the lesion, the catheter lost its suction.Even after the catheter was flushed, it did not suck properly again.The procedure was completed using another jetstream catheter.No patient complications were reported.
 
Event Description
It was reported that there was a loss of aspiration.A 2.1mm jetstream xc atherectomy catheter was selected for use in an atherectomy procedure.During the procedure, while milling through the lesion, the catheter lost its suction.Even after the catheter was flushed, it did not suck properly again.The procedure was completed using another jetstream catheter.No patient complications were reported.
 
Manufacturer Narrative
Device eval by manufacturer: 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 a buckled/kinked shaft located 1cm from the tip.There was blood in the device.Functional analysis was performed, and the rotation of the device did not function as designed.Aspiration testing of the device was performed, and the device performed as designed.Inspection of the remainder of the device revealed no damage or irregularities.The complaint was not confirmed for the reported evacuation failure.
 
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Brand Name
JETSTREAM XC ATHERECTOMY CATHETER
Type of Device
CATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
model farm road
cork T12 Y K88
EI   T12 YK88
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17799723
MDR Text Key324052038
Report Number2124215-2023-51533
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 Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 12/18/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0031759900
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/15/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/06/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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