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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 Problem Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/10/2018
Event Type  malfunction  
Event Description
It was reported that a device became stuck on a wire.A 2.4 mm jetstream xc catheter was selected for an atherectomy procedure in the left superficial femoral artery.At the end of the procedure during removal of the device, the jetstream because stuck on a non-bsc wire.Both the jetstream and non-bsc wire were able to be removed without complication.The patient experienced no harm or adverse events.
 
Event Description
It was reported that a device became stuck on a wire.A 2.4 mm jetstream xc catheter was selected for an atherectomy procedure in the left superficial femoral artery.At the end of the procedure during removal of the device, the jetstream because stuck on a non-bsc wire.Both the jetstream and non-bsc wire were able to be removed without complication.The patient experienced no harm or adverse events.
 
Manufacturer Narrative
Device eval by manufacturer: returned product consisted of a jetstream xc-2.4 atherectomy catheter with a.014 nav 6 filter wire stuck in the device.The device and the catheter shaft were analyzed for damage.Visual analysis showed 1 kink on the catheter shaft located 101.5cm from the tip.Functionality was completed by connecting the device to the jetstream console.The device functioned as designed.The customer stated that a nav 6 filter wire was used for this procedure which is not on the compatible guidewire list per the dfu.Microscopic analysis of the tip area showed that the device had been run over the coils of the guidewire.When the device is run too far distal and interference with the coils results, this could contribute to the guidewire sticking issues the customer experienced.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 Key8169708
MDR Text Key130531803
Report Number2134265-2018-64103
Device Sequence Number1
Product Code MCW
UDI-Device Identifier08714729889922
UDI-Public08714729889922
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,health
Type of Report Initial,Followup
Report Date 01/10/2019
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 Date09/05/2020
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0022756974
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2018
Initial Date Manufacturer Received 12/10/2018
Initial Date FDA Received12/17/2018
Supplement Dates Manufacturer Received12/21/2018
Supplement Dates FDA Received01/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NAV6 WIRE; NAV6 WIRE; NAV6 WIRE
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