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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 No Consequences Or Impact To Patient (2199)
Event Date 11/26/2018
Event Type  malfunction  
Event Description
It was reported that the catheter stopped drilling.A 2.1mm jetstream catheter was selected for an athrectomy procedure in the superficial femoral artery (sfa).During the procedure, the catheter stopped drilling.The procedure was completed with another of the same device.There were no patient complications reported.
 
Manufacturer Narrative
Device analysis: returned product consisted of a jetstream xc-2.1 atherectomy catheter.The shaft and the remainder of the device were inspected for damage.Visual examination showed that the baton was cut from the returned device.With the baton being cut and no infusion or aspiration lines the device cannot be functionally tested.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint for device rotational issues were not confirmed due to the incomplete device being returned for analysis.
 
Event Description
It was reported that the catheter stopped drilling.A 2.1mm jetstream catheter was selected for an athrectomy procedure in the superficial femoral artery (sfa).During the procedure, the catheter stopped drilling.The procedure was completed with another of the same device.There were no patient complications reported.
 
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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 Key8156102
MDR Text Key130185263
Report Number2134265-2018-63642
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
PMA/PMN Number
K133023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/12/2020
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0022238542
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2018
Date Manufacturer Received01/02/2019
Patient Sequence Number1
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