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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 Mechanical Problem (1384); Difficult to Advance (2920)
Patient Problems Pain (1994); Perforation of Vessels (2135)
Event Date 10/23/2018
Event Type  Injury  
Event Description
(b)(6) study. It was reported that the patient experienced a perforation and pain. The 100% stenosed, 4mmx80mm, tasc ii b target classified lesion was located in the left distal superficial femoral artery. The lesion was treated with a 2. 1 mm jetstream xc atherectomy catheter and jetstream console. After the guide wire passed through the lesion and through the true cavity, the jetstream catheter was rotated once; however, due to a malfunction, the device failed. At this time subject experienced pain. Due to the pain, a piperidine injection was injected 50 mg intramuscularly. A second attempt was made to insert the jetstream catheter; however it failed to pass through the lesion. Hence, the catheter was pulled out and flushed in-vitro. A third attempt was made with the same catheter; however the catheter was unable to be pushed forward and during this, a vascular perforation was noted. The location of the perforation was a segment of target lesion detected through angiography. Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed followed by stent implantation to stop the bleeding, with 0 % final residual stenosis. Both of the events were considered to be recovered/resolved.
 
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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 Key8071378
MDR Text Key127167142
Report Number2134265-2018-62884
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeCH
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,Followup,Followup
Report Date 01/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2019
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0021375755
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/13/2017
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: 11/14/2018 Patient Sequence Number: 1
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