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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); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation of Vessels (2135)
Event Date 06/13/2019
Event Type  Injury  
Event Description
It was reported that the blood vessel ruptured.A 2.4 mm jetstream xc atherectomy catheter was selected a percutaneous transluminal angioplasty procedure in the distal superficial femoral artery (sfa).During the procedure, after a second pass with the blades running, the blades stopped spinning.Angiography confirmed the sfa and the bifurcation of the collateral were ruptured.A mustang balloon and eluvia stent were used to stop the bleeding and cover the lesion.The patient condition was good after the procedure.
 
Manufacturer Narrative
Device code originally reported as adverse event without identified device or use problem 2993 and correct device code was updated to mechanical problem 1384.Device analysis by mfr: the returned product consisted of a jetstream xc 2.4mm atherectomy catheter.The shaft and the remainder of the device were inspected for damage.Visual examination showed no damage to the catheter shaft.The functionality of the device was checked by setting up the product per the directions for use.The device primed as designed.The device was functionally tested, and the device functioned as designed.The device was tested in blades up and blades down modes with no issues.Inspection of the remainder of the device, revealed no other damage or irregularities.
 
Event Description
It was reported that the blood vessel ruptured.A 2.4 mm jetstream xc atherectomy catheter was selected a percutaneous transluminal angioplasty procedure in the distal superficial femoral artery (sfa).During the procedure, after a second pass with the blades running, the blades stopped spinning.Angiography confirmed the sfa and the bifurcation of the collateral were ruptured.A mustang balloon and eluvia stent were used to stop the bleeding and cover the lesion.The patient condition was good after the procedure.
 
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Brand Name
JETSTREAM XC ATHERECTOMY CATHETER
Type of Device
CATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8771745
MDR Text Key150411361
Report Number2134265-2019-07910
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
PMA/PMN Number
K130637
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/17/2021
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0023659925
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2019
Date Manufacturer Received07/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age71 YR
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