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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 Unintended Movement (3026)
Patient Problems Embolism (1829); Pain (1994); Injury (2348)
Event Date 10/19/2018
Event Type  Injury  
Event Description
It was reported that the patient experienced pain and distal embolization occurred and an amputation was performed. A 2. 4mm jetstream xc atherectomy catheter was selected for an atherectomy procedure in the severely calcified lesion located on a third distal of the right superficial femoral artery (sfa). A 7mm non-bsc filter wire was used. The jetstream location was around 4cm lower than the distal lesion. The filter was positioned in the most healthy part of the vessel and looked well installed prior to turning on the jetstream catheter. During atherectomy, the filter slightly moved, even though it was held by the physician. Two passes with blades down and two passes with blades up for a total time of 7. 18 minutes were performed. No performance issues were noted with the jetstream device. Rex all the time and catheter moves very slowly. 150ml of contrast was used. After the four passes, the patient started to have pain under the right knee. Distal emboli was noticed after. The filter contained many calcium debris. The procedure was completed with a non-bsc drug coated balloon (dcb) and other percutaneous transluminal angioplasty (pta) balloons and guidewires trying to aspirate distal debris and dilate the distal vessels. Prior case, the patient had a high chance to have a below the knee amputation. A below the knee amputation was done on (b)(6) 2018 on the patient's right leg. No other patient complications were reported.
 
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Brand NameJETSTREAM XC ATHERECTOMY CATHETER
Type of DeviceCATHETER, 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 Key8033434
MDR Text Key125964794
Report Number2134265-2018-62532
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K130637
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/29/2020
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0022317503
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/29/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/02/2018 Patient Sequence Number: 1
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