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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 Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/16/2024
Event Type  malfunction  
Event Description
It was reported that guidewire entrapment occurred.The target lesion was located in the distal superficial femoral artery and the popliteal artery ostium.A 2.1mm jetstream xc atherectomy catheter was selected to treat the peripheral claudication.The catheter was being used per the instructions for use, and the operator was able to complete two blades-up and blades-down passes; however, the jetstream catheter was unable to be backed out over the wire.The entire jetstream catheter along with the non-boston scientific (bsc) filter and guidewire had to be removed together.Upon closer inspection, it was noticed that the non-bsc guidewire was delaminating.No other visible defects were noticed.The procedure was completed with percutaneous transluminal angioplasty and a drug-eluting stent.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluation by manufacturer: the returned product to boston scientific consisted of a jetstream xc-2.1 atherectomy catheter.No guidewire returned in or with the device.The device and the catheter shaft were analyzed for damage.Visual examination showed a kink located 73.5cm from the tip.The device was set up per the instructions for use and the device primed and ran as designed.A.014 test thruway guidewire was used to verify guidewire lumen patency.The guidewire was inserted into the device and the wire transcended through the device with a slight restriction due to the kinked shaft.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was not confirmed for guidewire sticking; however, shaft damage was confirmed.
 
Event Description
It was reported that guidewire entrapment occurred.The target lesion was located in the distal superficial femoral artery and the popliteal artery ostium.A 2.1mm jetstream xc atherectomy catheter was selected to treat the peripheral claudication.The catheter was being used per the instructions for use, and the operator was able to complete two blades-up and blades-down passes; however, the jetstream catheter was unable to be backed out over the wire.The entire jetstream catheter along with the non-boston scientific (bsc) filter and guidewire had to be removed together.Upon closer inspection, it was noticed that the non-bsc guidewire was delaminating.No other visible defects were noticed.The procedure was completed with percutaneous transluminal angioplasty and a drug-eluting stent.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
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
model farm road
cork T12 Y K88
EI   T12 YK88
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18654809
MDR Text Key334748025
Report Number2124215-2024-06314
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number45007
Device Catalogue Number45007
Device Lot Number0032648656
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/29/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/16/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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