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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 Device Damaged by Another Device (2915); Device-Device Incompatibility (2919); Mechanical Jam (2983); Physical Resistance/Sticking (4012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/20/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the guidewire fractured.A 2.4 mm jetstream xc catheter was selected for an atherectomy procedure in an unspecified location of the superficial femoral artery (sfa).A non-bsc wire was used in conjunction with the jetstream.During the procedure, the jetstream became difficult to remove from the wire.Upon removing the jetstream from the wire, the wire fractured.A piece of the broken wire remained in the artery.It was then entirely removed from the artery with a forceps.At this point, the procedure was finished with a balloon and stent.The patient experienced no adverse effects and is fine.
 
Event Description
It was reported that the guidewire fractured.A 2.4 mm jetstream xc catheter was selected for an atherectomy procedure in an unspecified location of the superficial femoral artery (sfa).A non-bsc wire was used in conjunction with the jetstream.During the procedure, the jetstream became difficult to remove from the wire.Upon removing the jetstream from the wire, the wire fractured.A piece of the broken wire remained in the artery.It was then entirely removed from the artery with a forceps.At this point, the procedure was finished with a balloon and stent.The patient experienced no adverse effects and is fine.
 
Manufacturer Narrative
Initial reporter state - (b)(6).Device eval by manufacturer: returned product consisted of a jetstream xc-2.4 atherectomy catheter.The guidewire was protruding out of the proximal end of the device.Visual analysis showed one severe kink located 41cm from the tip.It was noticed that the guidewire was stuck in the device and protruding from the proximal end of the device approximately 120cm.The wire was pulled from the device with little effort.Functional testing was performed, and the device ran as designed.A.014 test guidewire was used to insert in the device to check for lumen patency.The guidewire transcended through the device approximately 120cm from the tip at the point of the kink and stopped.The guidewire restriction was confirmed.No other damage or irregularities were noted on the device.Adverse event/product problem was corrected from adverse event to product problem.Outcomes attrib to adv event was corrected from required intervention to prevent permanent impairment/damage to none.Device codes were corrected from 2919 and 2983 to 2915 and 4012.
 
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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 Key8499881
MDR Text Key141476164
Report Number2134265-2019-03667
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 05/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/28/2020
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0022440255
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2019
Initial Date Manufacturer Received 03/20/2019
Initial Date FDA Received04/10/2019
Supplement Dates Manufacturer Received04/24/2019
Supplement Dates FDA Received05/09/2019
Patient Sequence Number1
Treatment
ABBOTT HI-TORQUE SPARTACORE GUIDEWIRE; ABBOTT HI-TORQUE SPARTACORE GUIDEWIRE; ABBOTT HI-TORQUE SPARTACORE GUIDEWIRE
Patient Outcome(s) Required Intervention;
Patient Age51 YR
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