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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION JETSTREAM ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Device Problems Entrapment of Device (1212); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2018
Event Type  malfunction  
Event Description
It was reported that the device stuck on the wire.A jetstream atherectomy catheter was selected for use in an atherectomy procedure.During the procedure inside the patient's body, the device crossed.Upon finishing the procedure, the device stuck a bit and some wire was lost as the device was pulled out and it was noted that the catheter partly wrinkled on itself at the tip.No patient complications were reported.
 
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Brand Name
JETSTREAM 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 CORK LIMITED
cork business technology park
model farm road
cork
EI  
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8171090
MDR Text Key130631444
Report Number2134265-2018-64406
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130637
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 12/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/10/2018
Initial Date FDA Received12/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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