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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE JETSTREAM® ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

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BOSTON SCIENTIFIC - MAPLE GROVE JETSTREAM® ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 030557-020
Device Problems Failure to Prime (1492); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Examination of the returned complaint device revealed that the outer infusion sheath on the catheter shaft had burst and was leaking fluid.The inner sheath on the catheter shaft has been stretched and compressed onto the spiral cut aspiration lumen causing the sheath to interfere with the drive coil rotation.Functional analysis was done by completing the set up procedure and was noticed that the priming sequence was not functioning properly due to the outer infusion sheath being ruptured.They removed the outer plastic shell on the pod and disconnected the drive coil shaft from the motor.After disconnecting, the forward and reverse buttons on the mouse control were pushed and the motor did run in both directions forward and reverse.Dissection of the catheter shaft showed that the inside of the exhaust lumen was completely occluded with a heavy clot burden.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
 
Event Description
Reportable based on analysis completed on 29jul2015.It was reported that during preparation, the device failed to prime.This 1.85mm jetstream atherectomy catheter was selected; however, the device would not prime and there was no motion from the distal tip of the catheter.The device was not used.The procedure was completed with a different device.No patient complications were reported and the patient's status is fine.However, device analysis revealed that the outer sheath burst.
 
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Brand Name
JETSTREAM® ATHERECTOMY CATHETER
Type of Device
CATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5032029
MDR Text Key24124304
Report Number2134265-2015-05729
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Report Date 07/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/03/2015
Device Model Number030557-020
Device Lot Number130403
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/26/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/30/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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