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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Embolism/Embolus (4438)
Event Date 01/15/2024
Event Type  Injury  
Manufacturer Narrative
B3: approximated based on the date the manufacturer became aware of the event.
 
Event Description
It was reported a distal embolism occurred during the procedure.A jetstream xc catheter was selected for interventional procedure.Physician indicated there was an embolism during the procedure.Additional information requests have been sent, to determine the patient outcome.
 
Manufacturer Narrative
B3: approximated based on the date the manufacturer became aware of the event.
 
Event Description
It was reported a distal embolism occurred during the procedure.A jetstream xc catheter was selected for interventional procedure.Physician indicated there was an embolism during the procedure.Insufficient information given to comment on patient condition.It was further reported that the jetstream xc catheter functioned as intended during an interventional procedure for a patient with rutherford class 3 peripheral artery disease (pad).Imaging prior to the use of jetstream showed tibial vessels patent.An angiogram after the use of jetstream revealed the emboli lodged into the peroneal vessel.Angioplasty of the posterior tibial vessel was performed using a sterling balloon.Heparin was given to the patient throughout the case.The embolism was successfully removed, and the artery was patent post procedure.
 
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Brand Name
JETSTREAM 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 Key18654984
MDR Text Key334703351
Report Number2124215-2024-06159
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/04/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/06/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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