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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM XC; CATHETER, PERIPHERAL, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION JETSTREAM XC; CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 45007
Device Problems Entrapment of Device (1212); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/05/2018
Event Type  malfunction  
Event Description
It was reported that the catheter cracked and became stuck on the wire.A 2.1mm jetstream xc atherectomy catheter and thruway guidewire were selected for an atherectomy procedure in the superficial femoral artery (sfa).During the procedure, it was noted that the jetstream device cracked and the wire was stuck in the catheter.Another of the same catheter and wire were used to completed the procedure.There were no patient complications and the patient's status is fine.
 
Event Description
It was reported that the catheter cracked and became stuck on the wire.A 2.1mm jetstream xc atherectomy catheter and thruway guidewire were selected for an atherectomy procedure in the superficial femoral artery (sfa).During the procedure, it was noted that the jetstream device cracked and the wire was stuck in the catheter.Another of the same catheter and wire were used to completed the procedure.There were no patient complications and the patient's status is fine.Device evaluated by mfr: returned product consisted of a jetstream xc-2.1 atherectomy catheter with a thruway guidewire wire stuck in the device.The device and the catheter shaft were analyzed for damage.Visual analysis showed that the device presented multiple severe kinks throughout the catheter length.The guidewire was pulled from the device with some restriction.The restriction that was felt during the extraction of the guidewire was consistent with the severe kinking of the device which made it difficult to remove the wire.Functionality was completed by connecting the device to the jetstream console.The device did not function as designed due to the severe shaft damage.The damage that was noticed looks to be consistent with procedural issues and most likely interference with the catheter guide sheath.Pushing, pulling and torqueing the device may cause the damaged noticed.No torn material was noticed on the catheter shaft.Inspection of the remainder of the device, revealed no damage or irregularities.
 
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Brand Name
JETSTREAM XC
Type of Device
CATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8116056
MDR Text Key128805153
Report Number2134265-2018-63302
Device Sequence Number1
Product Code MCW
UDI-Device Identifier08714729889892
UDI-Public08714729889892
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,health
Type of Report Initial,Followup
Report Date 12/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/20/2020
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0022408035
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2018
Date Manufacturer Received11/29/2018
Patient Sequence Number1
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